Cough
Conditions
Interventions
160 mg:Naringin tablets were taken orally in multiple doses of 160 mg (4 tablets) under fasting condition (once on the 1st day, three times from the 2nd to the 6th day, and once on the 7th day).
Placebo tablet:The appearance of placebo table is the same as naringin tablets. Placebo tablets were taken orally in multiple doses of 4 tablets under fasting condition (once on the 1st day, three tim
Sponsors
Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Participants were healthy males and females, aged 18 to 40 years old, >=50 kg weight, body mass index of 19 to 25 kg m2. The health condition of participants is good according to the screening medical history, physical examination, vital signs, and electrocardiogram and laboratory examination. 12-lead electrocardiogram and serum troponin I had to be normal at screening within 8 days of initial dosing, and serology for hepatitis C antibodies, hepatitis B surface antigen, HIV antibodies, syphilis antibodies, human immunodeficiency virus, and blood pregnancy tests had to be negative.Clinical laboratory test results had to be normal (sodium, potassium, total protein, white blood cell count, red blood cell count, hematocrit, hemoglobin, platelet count, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, blood urea nitrogen, creatinine, total bilirubin, alkaline phosphatase, creatine kinase, lactate dehydrogenase, calcium, chloride, phosphorus, albumin, globulin, cholesterol, triglycerides, glucose, uric acid, and urinalysis), and without other clinically significant abnormalities. Participants were required to use barrier contraception with spermicide during sexual intercourse during the study. During the trial, female participants were in the non-menstrual period, non-pregnant period and non-lactation period, and participants didnt smoke. Participants didn't plan pregnancy in six months later after the clinical trials. Participants can communicate with the investigator, understand and comply with the requirements of this study, and sign informed consent. And the concentration of blank plasma naringin <0.5 ng/mL and naringenin <2.0 ng/mL during the baseline visit period.
Exclusion criteria
Exclusion criteria: Main exclusion criteria were history of clinically significant disease, abnormality, or drug allergy, including a history or evidence of cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine/ metabolic, immunologic, dermatologic, neurologic, oncologic, or psychiatric illness or significant abnormalities, or any condition/surgical intervention known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Prior to clinical trials, participants were excluded if they had acute cough, subacute cough mediated by neurogenic inflammation (such as cough after cold), chronic bronchitis with chronic cough, bronchial asthma, chronic obstructive pulmonary disease, pulmonary cystic fibrosis, bronchiectasis and other respiratory diseases. Participants were also exclusionary, if they had abnormal chest radiographs or electrocardiogram parameters as followed: PR intervals of >210 ms, or QRS duration of >120 ms, or QTcB of >460 ms (male) or QTcB of >470 ms (female). The exclusion also included males and females who planned to have baby in six months later after the clinical trials. A history of significant tea or coffee consumption (>8 cups/day) was disallowed. Participation was excluded for treatment with any investigational product in a clinical study within four weeks; and use of any other drug, including prescription and non-prescription medications, herbal products, or dietary supplements within two weeks prior to dosing. In the baseline visit issue, if meet any of the following subjects, are not to enter the study: 1) within 48 hours before check-in I period room eating foods containing naringin or naringenin (including fruit juice, beans, ginger, apple, orange, grape, coffee, chocolate, tea); 2) within 48 hours before check-in I period room smoking or drinking; 3) within 48 hours before check-in I period ward strenuous exercise (such as strength training, aerobic training, football); 4) positive for alcohol breath test or drug abuse screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety in Chinese Healthy Volunteers (Adverse events; Laboratory inspection; Vital signs (sitting blood pressure, temperature and pulse) physical examination; and Electrocardiogram examination).;Pharmacokinetics of naringin tablets (Tmax, C ss-max, C ss-min, C ss-av, t 1/2, AUC 0-24,ss, AUC 0- 8 ,ss, AUC 0-24,ss / AUC 0-8,ss, CL/F, CLr/f); | — |
Countries
China
Contacts
Public ContactWeiwei Su
Sun Yat-sen University
Outcome results
None listed