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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Bromhexine Hydrochloride Tablet

• Registration Number: NCT04672707
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

The purpose is to study the pharmacokinetic characteristics and safety of bromine hexane hydrochloride in healthy adults after oral administration of bromine hexane hydrochloride tablets. Then to explore the mechanism related to the role of transmembrane serine proteases (TMPRSSs) through the study, and to provide the basis for the clinical rational administration of bromine hexane hydrochloride tablets.

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-17
• Study Start: 2020-12-28
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

1. Have participated in any clinical trial within 90 days before the trial or plan to participate in other clinical trials during the trial;

2. Have undergone major surgery within 90 days before the trial or plan to undergo surgery within 3 months after the trial;

3. 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;

4. 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);

5. 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.

6. 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;

7. History of substance abuse;

8. Urine screening for substance abuse (tetrahydrocannabinol, benzodiazepine, barbiturates, morphine, cocaine, methamphetamine) was positive;

9. 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);

10. Positive breath test;

11. 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 >;

12. 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);

13. There are special requirements for diet, during the test can not comply with a unified diet;

14. Subjects refused to comply with the 48-hour ban on caffeine, alcohol, grapefruit and food (including tea, chocolate, coffee, cola, etc.);

15. Participants with partners refused to use effective contraception within 180 days from screening to completion of the trial；

16. Female subjects were positive for blood/urine pregnancy;

17. (c) Persons with renal insufficiency, impairment or previous urinary system disease;

18. hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;

19. Halo acupuncture, halo blood and venous blood collection difficulties;

20. The physical examination has an obvious abnormality, and the researcher thinks it is not suitable to participate in the experiment;

21. Electrocardiogram examination has an obvious abnormality, and the researcher thinks it is not suitable to participate in the experiment;

22. Blood biochemistry, blood routine, urine routine examination have obvious abnormal, and the researchers think it is not suitable to participate in the test;

23. The subjects may not be able to complete the study for other reasons or may not be suitable for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Bromhexine Hydrochloride Tablet	Bromhexine Hydrochloride Tablet, 64 mg ,8 mg spec 8 tablets ,3 times daily ,2 days in succession)
Group D	Bromhexine Hydrochloride Tablet	Bromhexine Hydrochloride Tablets, 80 mg ,8 mg Standard preparation 10 tablets ,3 times a day ,2 day
Group A	Bromhexine Hydrochloride Tablet	Bromhexine Hydrochloride Tablet, 32 mg, 8 mg 4 tablets, three times a day, for 2 days
Group B	Bromhexine Hydrochloride Tablet	Bromhexine Hydrochloride Tablet, 48 mg, 8 mg 6 tablets, three times a day, continuous service within 2 days

Primary Outcome Measures

Name	Time	Method
Cmax	up to 48 hours	Maximum observed concentration

Secondary Outcome Measures

Name	Time	Method
Time of maximum concentration (Tmax)	2 to 2.5 hours	16 hour dosing period; 3 dosing periods each separated by 2 day washout
Area under curve (AUC 0-16h)	up to 48 hours	16 hour dosing period; 3 dosing periods each separated by 2 day washout
Clearance rate（CL）	up to 48 hours	Apparent clearance rate
AUC(AUC to infinity)	up to 48 hours	16 hour dosing period; 3 dosing periods each separated by 2 day washout
Vd	up to 48 hours	Apparent volume of distribution
t1/2	5 hour	16 hour dosing period; 3 dosing periods each separated by 2 day washout
λz	up to 48 hours	Terminal disposition rate constant
AUC_%Extrap	up to 48 hours	The proportion of the AUC (AUC to infinity) from the last point until we theoretically extrapolate to infinity

Trial Locations

Locations (1)

The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study; 🇨🇳 Wenzhou, Zhejiang, China