Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition
NCT ID: NCT01682577
Last Updated: 2012-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2008-09-30
2008-12-31
Brief Summary
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Detailed Description
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Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration.
Three weeks after the first drug administration (washout period), the procedure was repeated using the alternate drug.
The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined based on the concentrations of the perindopril parent compound and the metabolite perindoprilat, using high-performance liquid chromatography method with tandem mass spectrometry detector (LC-MS/MS).
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Perindopril 4 mg tablets of PT Dexa Medica
Group I (Test product): each tablet contains perindopril tert-butylamine salt 4 mg.
A single dose of perindopril tablet of PT Dexa Medica was given to each of study subjects.
Perindopril 4 mg tablets of PT Dexa Medica
Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Perindopril 4 mg tablets of Servier
Group II (Reference product) : each tablet contains perindopril tert-butylamine salt 4 mg.
A single dose of perindopril (Prexum) tablets of Servier was given to each of study subjects.
Perindopril 4 mg tablets of Servier
Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Interventions
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Perindopril 4 mg tablets of PT Dexa Medica
Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Perindopril 4 mg tablets of Servier
Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Dexa Medica Group
INDUSTRY
Responsible Party
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Principal Investigators
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Danang A Yunaidi, MD
Role: PRINCIPAL_INVESTIGATOR
PT Equilab International
Locations
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PT Equilab International
Jakarta, Jakarta Special Capital Region, Indonesia
Countries
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References
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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. doi: 10.1046/j.0306-5251.2001.01410.x.
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. doi: 10.1097/00005344-199209000-00024.
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. doi: 10.1111/j.1365-2125.1992.tb04006.x.
Other Identifiers
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PR.122/EQL/2008
Identifier Type: -
Identifier Source: org_study_id