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出境医 / 临床实验 / A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects

A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects

Study Description
Brief Summary:
Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects.

Condition or disease Intervention/treatment Phase
Cough Drug: Group A: Benzonatate 100mg Drug: Group B: Benzonatate 200mg Drug: Group C: Benzonatate 400mg Phase 1

Detailed Description:
Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects. The study was designed to be single-center, open, and parallel, there are 3 groups A, B, C, each group will be enrolled in 12 healthy adult subjects. Single-dose of pharmacokinetics will be carried out in group A and C, single-dose and multiple-dose of pharmacokinetics will be carried out in group B. Subjects in group A and C will be given benzonatate of 100mg and 400mg respectively, Subjects in group B will be given benzonatate of 200mg. Subjects in group A and C will be given benzonatate once after a 10-hour fast in the first day of the trail. Subjects in group B will be given benzonatate once after a 10-hour fast in the first day of the trail, and they will be given benzonatate thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate once after a 10-hour fast. After completing blood collection and safety inspection at the appropriate time points, subjects can leave the test center. The main pharmacokinetic parameters will be calculated, to fully reflect the characteristics of drug absorption, distribution, metabolism and excretion in human body. The main pharmacokinetic parameters include Tmax, Cmax, Css, AUC0-t, AUC0-∞, λz, t1/2, Vd/F, CL/F, and so on.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Single-dose and Multiple-dose Pharmacokinetic Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : February 27, 2019
Estimated Study Completion Date : April 30, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Benzonatate Drug: Group A: Benzonatate 100mg
Subjects in group A will be given benzonatate 100mg once after a 10-hour fast in the first day of the trail

Drug: Group B: Benzonatate 200mg
Subjects in group B will be given benzonatate 200mg once after a 10-hour fast in the first day of the trail, and they will be given benzonatate 200mg thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate 200mg once after a 10-hour fast.

Drug: Group C: Benzonatate 400mg
Subjects in group C will be given benzonatate 400mg once after a 10-hour fast in the first day of the trail
Outcome Measures
Primary Outcome Measures :
  1. Tmax [ Time Frame: day 1 and day 4 ]
    Time to peak

  2. Cmax [ Time Frame: day 1 and day 4 ]
    peak plasma concentration

  3. t1/2 [ Time Frame: day 1 and day 4 ]
    elimination half-life time

  4. AUC0-t [ Time Frame: day 1 and day 4 ]
    Area under the plasma concentration versus time curve from the medication to the last time the concentration can be measured

  5. AUC0-∞ [ Time Frame: day 1 and day 4 ]
    Area under the plasma concentration versus time curve from the medication extrapolate the infinity time

  6. CL/F [ Time Frame: day 1 and day 4 ]
    elimination ratio


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. You should fully understand the testing content, process and adverse reaction. Freely given informed consent.

    2. Male or Female ages 18 through 45 (include 18 and 45).

    3. The male subjects weighed more than 50 kg, the female subjects weighed more than 45kg. Body Mass Index(BMI) between 18 and 28, BMI=Weight(kg)/Height2(m2).

Exclusion Criteria:

  • 1. Allergy to benzonatate, allergic constitution (Allergic to a variety of medicines and foods).

    2. Abnormal physical examination and abnormal vital signs, and have clinical significance.

    3. Abnormal results of laboratory studies and have clinical significance. 4. Abnormal electrocardiogram and have clinical significance. 5. The hepatitis B surface antigen(HbsAg), hepatitis C antibody, HIV antibody and antigen, Treponema pallidum antibody（TP-Ab）were positive.

    6. Patients with cardiovascular system, urinary system, digestive system, nervous system, respiratory system, mental or immunodeficiency diseases.

    7. Dysphagia or with gastrointestinal history influencing drug absorption. 8. Patients with any diseases that increase the risk of bleeding (e.g. acute gastritis, duodenal ulcer, and so on).

    9. Patients smoked more than 5 cigarettes a day in the first 3 months of screening 10. Alcohol breath test were positive (blood-alcohol concentration>0.0mg/100ml) , or have history of alcoholism (more than 14 units of alcohol every week, 1 unit is equal to 285ml of beer, 25ml of spririts, or 100ml of wine.

    11. Drug abuse screening were positive by urinalysis, or have a history of substance abuse or taken drugs last 3 years.

    12. Subjects (or his fere) have family planning in the next 3 months, or can't take effective contraceptive measures in the next 3 months.

    13. Female subjects during lactation, the quantitative of β-HCG exceed the upper limit of normal range.

    14. Donate blood or massive blood loss (>450ml) in the first 3 months of screening.

    15. Taken any drugs that can inhibit the activity of liver enzyme in the first 28 days of screening, or taken the inhibitor or inducer of CYP3A4, P-gp, Bcrp, such as Itraconazole, Ketoconazole, Dronedarone.

    16. Taken any prescription drugs, OTC, vitamin products or Chinese herbal medicine in the first 14 days of screening.

    17. Special diets (e.g. pitaya, mango, pomelo) or strenuous exercise in the first 14 days of screening, or other factors to influence drug absorption, distribution, metabolism and excretion.

    18. Have attended clinical trial in the first 3 months of screening 19. The patient can't finish the study according to protocol requirements. 20. Acute disease or simultaneous medication between screening stage and the first time taking study drugs.

    21. Have consumed any alcoholic or caffeinated food or beverage such as chocolate and coffee in the first 48 hours of taking the study drug.

    22. Investigator believes other factors not suitable for testing.

Contacts and Locations

Contacts
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Contact: Kun Lou 0311-67808817 loukun@mail.ecspc.com

Locations
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China, Hebei
Cspc Nbp Pharmaceutical.Co.Ltd Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Kun Lou    0311-67808817    loukun@mail.ecspc.com   
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Yang Lin, M.D. Beijing Anzhen Hospital
Principal Investigator: Shan Jing, M.D. Beijing Anzhen Hospital
Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE September 10, 2018
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Tmax [ Time Frame: day 1 and day 4 ]
    Time to peak
  • Cmax [ Time Frame: day 1 and day 4 ]
    peak plasma concentration
  • t1/2 [ Time Frame: day 1 and day 4 ]
    elimination half-life time
  • AUC0-t [ Time Frame: day 1 and day 4 ]
    Area under the plasma concentration versus time curve from the medication to the last time the concentration can be measured
  • AUC0-∞ [ Time Frame: day 1 and day 4 ]
    Area under the plasma concentration versus time curve from the medication extrapolate the infinity time
  • CL/F [ Time Frame: day 1 and day 4 ]
    elimination ratio
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
Official Title  ICMJE The Single-dose and Multiple-dose Pharmacokinetic Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
Brief Summary Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects.
Detailed Description Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects. The study was designed to be single-center, open, and parallel, there are 3 groups A, B, C, each group will be enrolled in 12 healthy adult subjects. Single-dose of pharmacokinetics will be carried out in group A and C, single-dose and multiple-dose of pharmacokinetics will be carried out in group B. Subjects in group A and C will be given benzonatate of 100mg and 400mg respectively, Subjects in group B will be given benzonatate of 200mg. Subjects in group A and C will be given benzonatate once after a 10-hour fast in the first day of the trail. Subjects in group B will be given benzonatate once after a 10-hour fast in the first day of the trail, and they will be given benzonatate thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate once after a 10-hour fast. After completing blood collection and safety inspection at the appropriate time points, subjects can leave the test center. The main pharmacokinetic parameters will be calculated, to fully reflect the characteristics of drug absorption, distribution, metabolism and excretion in human body. The main pharmacokinetic parameters include Tmax, Cmax, Css, AUC0-t, AUC0-∞, λz, t1/2, Vd/F, CL/F, and so on.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cough
Intervention  ICMJE
  • Drug: Group A: Benzonatate 100mg
    Subjects in group A will be given benzonatate 100mg once after a 10-hour fast in the first day of the trail
  • Drug: Group B: Benzonatate 200mg
    Subjects in group B will be given benzonatate 200mg once after a 10-hour fast in the first day of the trail, and they will be given benzonatate 200mg thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate 200mg once after a 10-hour fast.
  • Drug: Group C: Benzonatate 400mg
    Subjects in group C will be given benzonatate 400mg once after a 10-hour fast in the first day of the trail
Study Arms  ICMJE Experimental: Benzonatate
Interventions:
  • Drug: Group A: Benzonatate 100mg
  • Drug: Group B: Benzonatate 200mg
  • Drug: Group C: Benzonatate 400mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. You should fully understand the testing content, process and adverse reaction. Freely given informed consent.

    2. Male or Female ages 18 through 45 (include 18 and 45).

    3. The male subjects weighed more than 50 kg, the female subjects weighed more than 45kg. Body Mass Index(BMI) between 18 and 28, BMI=Weight(kg)/Height2(m2).

Exclusion Criteria:

  • 1. Allergy to benzonatate, allergic constitution (Allergic to a variety of medicines and foods).

    2. Abnormal physical examination and abnormal vital signs, and have clinical significance.

    3. Abnormal results of laboratory studies and have clinical significance. 4. Abnormal electrocardiogram and have clinical significance. 5. The hepatitis B surface antigen(HbsAg), hepatitis C antibody, HIV antibody and antigen, Treponema pallidum antibody（TP-Ab）were positive.

    6. Patients with cardiovascular system, urinary system, digestive system, nervous system, respiratory system, mental or immunodeficiency diseases.

    7. Dysphagia or with gastrointestinal history influencing drug absorption. 8. Patients with any diseases that increase the risk of bleeding (e.g. acute gastritis, duodenal ulcer, and so on).

    9. Patients smoked more than 5 cigarettes a day in the first 3 months of screening 10. Alcohol breath test were positive (blood-alcohol concentration>0.0mg/100ml) , or have history of alcoholism (more than 14 units of alcohol every week, 1 unit is equal to 285ml of beer, 25ml of spririts, or 100ml of wine.

    11. Drug abuse screening were positive by urinalysis, or have a history of substance abuse or taken drugs last 3 years.

    12. Subjects (or his fere) have family planning in the next 3 months, or can't take effective contraceptive measures in the next 3 months.

    13. Female subjects during lactation, the quantitative of β-HCG exceed the upper limit of normal range.

    14. Donate blood or massive blood loss (>450ml) in the first 3 months of screening.

    15. Taken any drugs that can inhibit the activity of liver enzyme in the first 28 days of screening, or taken the inhibitor or inducer of CYP3A4, P-gp, Bcrp, such as Itraconazole, Ketoconazole, Dronedarone.

    16. Taken any prescription drugs, OTC, vitamin products or Chinese herbal medicine in the first 14 days of screening.

    17. Special diets (e.g. pitaya, mango, pomelo) or strenuous exercise in the first 14 days of screening, or other factors to influence drug absorption, distribution, metabolism and excretion.

    18. Have attended clinical trial in the first 3 months of screening 19. The patient can't finish the study according to protocol requirements. 20. Acute disease or simultaneous medication between screening stage and the first time taking study drugs.

    21. Have consumed any alcoholic or caffeinated food or beverage such as chocolate and coffee in the first 48 hours of taking the study drug.

    22. Investigator believes other factors not suitable for testing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922373
Other Study ID Numbers  ICMJE EY20170502
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study Sponsor  ICMJE CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yang Lin, M.D. Beijing Anzhen Hospital
Principal Investigator: Shan Jing, M.D. Beijing Anzhen Hospital
PRS Account CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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