Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Perindopril

Criteria

Inclusion Criteria:

• Healthy male and female subjects

• Aged 18-55 years inclusive

• A body mass index in the range of 18-25 kg/m2

• Able to participate, communicate well with the investigators and willing to give informed consent

• Non-smokers

• Vital signs (after 10 minutes resting) are within the following ranges:

• systolic blood pressure 100-125 mmHg

• diastolic blood pressure 60-80 mmHg

• pulse rate 60-90 bpm

Exclusion Criteria:

• Pregnant or lactating women

• Known hypersensitivity or contraindication to perindopril

• Intake of any prescription drug within 14 days of this study's first dosing day

• Intake of any non-prescription drug, food supplement, or herbal medicine within 7 days of this study's first dosing day

• History or presence of any liver dysfunction (ALT, alkaline phosphatase, total bilirubin ≥ 1.5 ULN)

• History of any bleeding or coagulation disorders

• Clinically significant ECG abnormalities

• Clinically significant haematology abnormalities

• Renal insufficiency (plasma creatinine concentration ≥ 1.4 mg/dL)

• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug

• A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day

• A positive hepatitis B surface antigen (HBsAg), anti-HCV, and anti-HIV

• History of drug or alcohol abuse within 12 months prior to screening of this study

• Participation in a previous study within 3 months of this study's first dosing day