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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Bromhexine Hydrochloride Tablet; Drug: Bromhexine Hydrochloride Tablet; Drug: Bromhexine Hydrochloride Tablet; Drug: Bromhexine Hydrochloride Tablet

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed concentration	up to 48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Expectorants; Respiratory System Agents; Bromhexine
• Other Study ID Numbers: BCYY-BEFA-2020BCCT002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No