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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
PT Equilab International
Jakarta, Jakarta Special Capital Region, Indonesia
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.
Time frame: 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.
Time frame: 192 hours
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.
Time frame: 192 hours
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.
Time frame: 192 hours
Time to achieve the peak plasma concentration (tmax)of perindopril parent compound
Time frame: 192 hours
Time to achieve the peak plasma concentration (tmax)of perindoprilat
Time frame: 192 hours
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Elimination half-life (t1/2)of perindopril parent compound
Time frame: 192 hours
Elimination half-life (t1/2)of perindoprilat
Time frame: 192 hours