Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Group 1:Phase I Synco (H.K.) Limited, Hong Kong produced Perindopril Erbumine Tablets
Phase II ACERTIL Table 4 mg (SERVIER HONG KONG LTD)
Group 2:Phase I: ACERTIL Table 4 mg (SERVIER HONG KONG LTD)
Phase II: Synco (H.K.) Limited, Hong Kong produced Perindopril Erbumine Tablets
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 55 years; 2. Male subjects weight greater than 50 kg, the female subjects weight greater than 45 kg, BMI 19 to 26( including boundary value); 3. All subjects are voluntary to take part in the trial and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Abnormalities in general physical examination or laboratory tests; 2. History of cardiovascular, haematological, hepatic, renal, biliary, gastrointestinal, psychological other acute diseases; 3. drug allergies and drug dependence; 4. AIDS and HIV positive; 5. Drug abusers; 6. Subjects in any clinical drug study within months before the study; 7. Smokers or alcohol consumers; 8. Treatment of other drugs within two weeks before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioequivalence; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Institute of Clinical Pharmacy, Central South University
Outcome results
None listed