Study on the Pharmacokinetics of Bromine Hexane Hydrochloride Tablets in Healthy Adults

NCT04672707 | Completed Phase 1

• 1 other identifier: BCYY-BEFA-2020BCCT002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is about increasing the dosage of bromine hexane hydrochloride to safety volume and continue to give it frequently in the new crown virus treatment could improve the efficacy.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Cmax

  Maximum observed concentration

  up to 48 hours

Secondary Outcomes (8)

• Area under curve (AUC 0-16h)

  up to 48 hours

• AUC(AUC to infinity)

  up to 48 hours

• AUC_%Extrap

  up to 48 hours

• Time of maximum concentration (Tmax)

  2 to 2.5 hours

• Clearance rate（CL）

  up to 48 hours

Study Arms (4)

Group A

EXPERIMENTAL

Bromhexine Hydrochloride Tablet, 32 mg, 8 mg 4 tablets, three times a day, for 2 days

Drug: Bromhexine Hydrochloride Tablet

Group B

EXPERIMENTAL

Bromhexine Hydrochloride Tablet, 48 mg, 8 mg 6 tablets, three times a day, continuous service within 2 days

Drug: Bromhexine Hydrochloride Tablet

Group C

EXPERIMENTAL

Bromhexine Hydrochloride Tablet, 64 mg ,8 mg spec 8 tablets ,3 times daily ,2 days in succession)

Drug: Bromhexine Hydrochloride Tablet

Group D

EXPERIMENTAL

Bromhexine Hydrochloride Tablets, 80 mg ,8 mg Standard preparation 10 tablets ,3 times a day ,2 day

Drug: Bromhexine Hydrochloride Tablet

Interventions

Bromhexine Hydrochloride Tablet DRUG

32 mg

Group A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and non-pregnant non-lactating females aged 18-55 years, including boundary values, trial period Over 55 years of age);
• Male body weight ≥50 kg, female body weight ≥45 kg, body mass index (BMI )19,282 Between, including boundary values;
• Health, no heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disease history;
• Sign informed consent before the trial, fully understand the content, process and possible adverse reactions, and communicate well with the researchers.

You may not qualify if:

• Have participated in any clinical trial within 90 days before the trial or plan to participate in other clinical trials during the trial;
• Have undergone major surgery within 90 days before the trial or plan to undergo surgery within 3 months after the trial;
• Blood loss or donation of more than 300 blood mL (excluding female physiological blood loss) within 90 days prior to the trial, or blood transfusion;
• Suffering from esophageal reflux, gastric bleeding or peptic ulcer disease within 180 days prior to the trial, more than once a week with heartburn, or any surgical procedure that may affect drug absorption (e.g. cholecystectomy);
• a person with a specific history of allergies (asthma, urticaria, eczema, etc.), or an allergic constitution (e.g. allergic to two or more drugs, food or pollen), or a known component of the drug\*or analogues/lactose allergy/intolerance;
• \*The main components of the test drug: bromine hexane hydrochloride, excipients: starch, lactose, magnesium stearate.
• Use of any medication within 28 days prior to the trial, including the use of prescription, over-the-counter and/or alternative medicines (e.g., medicinal meals, herbal medicines, hemostatic or health products) and the use of hormonal contraception or vaccines;
• History of substance abuse;
• Urine screening for substance abuse (tetrahydrocannabinol, benzodiazepine, barbiturates, morphine, cocaine, methamphetamine) was positive;
• More than 3 cigarettes per day during the 90 days before the test; Alcoholism, Over 7 drinks per week for women and over 14 drinks per week for men (1=150 mL wine =360 mL beer and 45 spirits);
• Positive breath test;
• The body temperature (ear temperature)≥37.5℃, the respiration was obviously abnormal, and the researchers thought it was not suitable to take part in the experiment. The systolic blood pressure \>140 mmHg or \<90 mmHg, diastolic blood pressure (diastolic blood pressure) was 90 mmHg or 60 times 100/min or \>;
• Positive human immunodeficiency virus antibody (HIV-Ab), hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) or Treponema pallidum specific antibody (TPHA);
• There are special requirements for diet, during the test can not comply with a unified diet;
• Subjects refused to comply with the 48-hour ban on caffeine, alcohol, grapefruit and food (including tea, chocolate, coffee, cola, etc.);

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Wanbangde Pharmaceutical Group Co., LTD: collaborator

Study Sites (1)

The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

Bromhexine

Intervention Hierarchy (Ancestors)

Aniline Compounds; Amines; Organic Chemicals; Cyclohexylamines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 17, 2020
• Study Start: December 28, 2020
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)