Healthy Volunteers
Conditions
Interventions
A:Phase 1: p.o reference product (fasting state)
Phase 2: p.o test product (fasting state)
Phase 3: p.o reference product (postprandial state)
Phase 4: p.o test product (postprandial state)
B:Phase 1: p.o test product (fasting state)
Phase 2: p.o reference product (fasting state)
Phase 3: p.o test product (postprandial state)
Phase 4: p.o reference product (postprandial state)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male Chinese volunteers aged from 18 to 40, BW more than 50 kg, and ages should not differ more than 10 years old between the volunteers; 2) BMI = weight (kg) / height 2 (m2),and a body mass index between 19 to 24. The weight of volunteers in same group should be similar; 3) Healthy status: no heart, liver, kidney, digestive system, nervous system, mental disorders and metabolic disorders and other medical history. The physical examination showed blood pressure, heart rate, ECG, respiratory system, liver function, kidney function and blood RT no abnormal; 4) No birth plan during the study and within three months after the study; 5) Signed the ICF before the study, and understood the content, process and adverse reactions might occur during the study; 6) Completed the study in accordance with the Protocol.
Exclusion criteria
Exclusion criteria: Volunteers were excluded if they have any clinically significant abnormality, have a history of an allergy or hypersensitivity to any chemicals, have donated blood or participated in another investigational drug study within 12 weeks before entry into this study, or have received any drug treatment within 2 weeks before the study. Volunteers with any history or evidence of a hepatic, renal, gastrointestinal, endocrine, pulmonary, hematological, cardiovascular, vascular, or collagen disease will also be excluded from this study. A history of muscle disease, nervous system disease, or a psychiatric disorder that might hinder compliance with the study protocol, as well as a history of alcohol, tobacco, or drug abuse, are also exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;plasma drug concentration; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Outcome results
None listed