- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682577
Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or one tablet of the reference drug (Prexum® 4 mg, Servier).
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jakarta, Indonesia, 12430
- PT Equilab International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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. |
Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Other Names:
|
ACTIVE_COMPARATOR: 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. |
Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under concentration-time curve (AUC)of perindopril parent compound
Time Frame: 192 hours
|
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
|
Area under concentration-time curve (AUC)of perindoprilat
Time Frame: 192 hours
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak plasma concentration (Cmax)of perindopril parent compound
Time Frame: 192 hours
|
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
|
Peak plasma concentration (Cmax)of perindoprilat
Time Frame: 192 hours
|
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
|
Time to achieve the peak plasma concentration (tmax)of perindopril parent compound
Time Frame: 192 hours
|
192 hours
|
|
Time to achieve the peak plasma concentration (tmax)of perindoprilat
Time Frame: 192 hours
|
192 hours
|
|
Elimination half-life (t1/2)of perindopril parent compound
Time Frame: 192 hours
|
192 hours
|
|
Elimination half-life (t1/2)of perindoprilat
Time Frame: 192 hours
|
192 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danang A Yunaidi, MD, PT. Equilab International
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR.122/EQL/2008
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