Healthy Clinical Trial
Official title:
Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets (Prexum® 4 mg, Servier)Under Fasting Condition
Verified date | September 2012 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | PT Equilab International | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Bellissant E, Giudicelli JF. Pharmacokinetic-pharmacodynamic model for perindoprilat regional haemodynamic effects in healthy volunteers and in congestive heart failure patients. Br J Clin Pharmacol. 2001 Jul;52(1):25-33. — View Citation
Louis WJ, Workman BS, Conway EL, Worland P, Rowley K, Drummer O, McNeil JJ, Harris G, Jarrott B. Single-dose and steady-state pharmacokinetics and pharmacodynamics of perindopril in hypertensive subjects. J Cardiovasc Pharmacol. 1992 Sep;20(3):505-11. — View Citation
Sennesael J, Ali A, Sweny P, Vandenburg M, Slovic D, Dratwa M, Resplandy G, Genissel P, Desche P. The pharmacokinetics of perindopril and its effects on serum angiotensin converting enzyme activity in hypertensive patients with chronic renal failure. Br J Clin Pharmacol. 1992 Jan;33(1):93-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under concentration-time curve (AUC)of perindopril parent compound | Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of perindopril parent compound. | 192 hours | No |
Primary | Area under concentration-time curve (AUC)of perindoprilat | Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of the active metabolite, perindoprilat. | 192 hours | No |
Secondary | Peak plasma concentration (Cmax)of perindopril parent compound | Relative bioavailability (secondarily measured by Cmax) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The Cmax was measured based on the plasma concentration of perindopril parent compound. | 192 hours | No |
Secondary | Peak plasma concentration (Cmax)of perindoprilat | Relative bioavailability (secondarily measured by Cmax) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The Cmax was measured based on the plasma concentration of the active metabolite, perindoprilat. | 192 hours | No |
Secondary | Time to achieve the peak plasma concentration (tmax)of perindopril parent compound | 192 hours | No | |
Secondary | Time to achieve the peak plasma concentration (tmax)of perindoprilat | 192 hours | No | |
Secondary | Elimination half-life (t1/2)of perindopril parent compound | 192 hours | No | |
Secondary | Elimination half-life (t1/2)of perindoprilat | 192 hours | No |
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