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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perindopril 4 mg tablets of PT Dexa Medica | Experimental | 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 Servier | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perindopril 4 mg tablets of PT Dexa Medica | Drug | Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danang A Yunaidi, MD | PT Equilab International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT Equilab International | Jakarta | Jakarta Special Capital Region | 12430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11453887 | Background | 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. | |
| 1279299 | Background | 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. |
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| ID | Term |
|---|---|
| D020913 | Perindopril |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Perindopril 4 mg tablets of Servier | Drug | Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study. |
|
|
| 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 |
| Time to achieve the peak plasma concentration (tmax)of perindopril parent compound | 192 hours |
| Time to achieve the peak plasma concentration (tmax)of perindoprilat | 192 hours |
| Elimination half-life (t1/2)of perindopril parent compound | 192 hours |
| Elimination half-life (t1/2)of perindoprilat | 192 hours |
| 1311597 | Background | 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. |