Healthy Clinical Trial
Official title:
Bioequivalence Study of 10 mg Lisinopril Tablets (Lisinopril 10 mg) Produced by PT Dexa Medica in Comparison With The Innovator Tablets (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, Under License From Astra Zeneca UK Ltd.)
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.)
This was a randomized, single-blind, two-period, two-sequence, cross-over study under
fasting condition. The participating subjects were required to have an overnight fast and in
the next morning were given orally one tablet of the test drug (Lisinopril 10 mg, produced
by PT Dexa Medica) or one tablet of the reference drug (Zestril® 10 mg, PT Boehringer
Ingelheim Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.).
Blood samples were drawn immediately before taking the drug (control), and at 1, 2, 3, 4, 5,
6, 7, 8, 9, 10, 12, 16, 24, 36, and 48 hours after drug administration. Seven days 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 from plasma concentrations of lisinopril, using liquid chromatography with tandem
mass spectrometry detection (LC-MS/MS) method.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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