Bioequivalence study of 10 mg ramipril tablets in healthy Thai volunteers

• Published in: Journal of the Medical Association of Thailand Vol. 94; no. 10; p. 1260
• Main Authors: Chatsiricharoenkul, Somruedee, Thangboonjit, Weerawon, Pongnarin, Piyapat, Konhan, Kanitta, Sathirakul, Korbtham, Kongpatanakul, Supornchai
• Format: Journal Article
• Language: English
• Published: Thailand 01-10-2011
• Subjects: Administration, Oral; Adolescent; Adult; Angiotensin-Converting Enzyme Inhibitors - administration & dosage; Angiotensin-Converting Enzyme Inhibitors - blood; Angiotensin-Converting Enzyme Inhibitors - pharmacokinetics; Asian Continental Ancestry Group; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Cross-Over Studies; Female; Humans; Male; Middle Aged; Ramipril - administration & dosage; Ramipril - blood; Ramipril - pharmacokinetics; Reference Values; Tablets; Tandem Mass Spectrometry; Thailand; Therapeutic Equivalency; Young Adult; Thailand
• ISSN: 0125-2208

To determine the bioequivalence of 10 mg dose of ramipril tablets between the test product (Ramtace 10 mg, Unison Laboratories, Thailand) and the reference product (Tritace 10 mg, Aventis Pharma SPA, Italy).
The present study was carried out with a single dose, 2-treatment, 2-period, 2-sequence randomized crossover design under fasting condition with a minimum of 14 days washout period in 24 healthy Thai male and female volunteers. Plasma samples for determination of ramipril and ramiprilat were obtained pre-dose and at frequent intervals for up to 72 h post dose. Ramipril and ramiprilat plasma concentrations were quantified by a validated method employing high performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS). All ofthe pharmacokinetic parameters were investigated using non-compartmental analysis.
The result demonstrated the 90% confidence interval (90%CI) of the geometric mean ratio (test/reference) of C max, AUC(0-72) and AUC(0-infinity) of ramipril were 97.26% (84.50%-111.93%), 100.70% (89.47%-113.34%) and 100.29% (88.90% 113.15%), respectively. For ramiprilat, the 90% CI for C max, AUC(0-72), and AUC(0-infinity) were 108.87% (103.00%-115.07%), 104.93% (100.50%-109.55%) and 103.30% (98.03%-108.85%), respectively.
the 90% confidence intervals for log-transformed geometric mean test/reference formulation ratios of primary parameters were entirely within 80.00%-125.00%. Thus, it can be concluded that the test formulation was bioequivalent to the reference formulation.