A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects

NCT03922373 | Unknown Phase 1 DMC

• 1 other identifier: EY20170502
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (6)

• Tmax

  Time to peak

  day 1 and day 4

• Cmax

  peak plasma concentration

  day 1 and day 4

• t1/2

  elimination half-life time

  day 1 and day 4

• AUC0-t

  Area under the plasma concentration versus time curve from the medication to the last time the concentration can be measured

  day 1 and day 4

• AUC0-∞

  Area under the plasma concentration versus time curve from the medication extrapolate the infinity time

  day 1 and day 4

• CL/F

  elimination ratio

  day 1 and day 4

Study Arms (1)

Benzonatate

EXPERIMENTAL

Drug: Group A: Benzonatate 100mg; Drug: Group B: Benzonatate 200mg; Drug: Group C: Benzonatate 400mg

Interventions

Group A: Benzonatate 100mg DRUG

Subjects in group A will be given benzonatate 100mg once after a 10-hour fast in the first day of the trail

Benzonatate

Group B: Benzonatate 200mg DRUG

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.

Benzonatate

Group C: Benzonatate 400mg DRUG

Subjects in group C will be given benzonatate 400mg once after a 10-hour fast in the first day of the trail

Benzonatate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. You should fully understand the testing content, process and adverse reaction. Freely given informed consent.
• \. Male or Female ages 18 through 45 (include 18 and 45).
• \. 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).

You may not qualify if:

• \. Allergy to benzonatate, allergic constitution (Allergic to a variety of medicines and foods).
• \. Abnormal physical examination and abnormal vital signs, and have clinical significance.
• \. 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.
• \. Patients with cardiovascular system, urinary system, digestive system, nervous system, respiratory system, mental or immunodeficiency diseases.
• \. 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).
• \. 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.
• \. Drug abuse screening were positive by urinalysis, or have a history of substance abuse or taken drugs last 3 years.
• \. Subjects (or his fere) have family planning in the next 3 months, or can't take effective contraceptive measures in the next 3 months.
• \. Female subjects during lactation, the quantitative of β-HCG exceed the upper limit of normal range.
• \. Donate blood or massive blood loss (\>450ml) in the first 3 months of screening.
• \. 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.
• \. Taken any prescription drugs, OTC, vitamin products or Chinese herbal medicine in the first 14 days of screening.
• \. 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.
• \. 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.
• \. Have consumed any alcoholic or caffeinated food or beverage such as chocolate and coffee in the first 48 hours of taking the study drug.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Cspc Nbp Pharmaceutical.Co.Ltd

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Lin, M.D.

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Shan Jing, M.D.

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Lou

CONTACT

0311-67808817; loukun@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: April 19, 2019
• Study Start: September 10, 2018
• Primary Completion: February 27, 2019
• Study Completion: April 30, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)