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

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.