Publication: Bioequivalence Study of 10 mg Ramipril Tablets in Healthy Thai Volunteers
11
Issued Date
2011-10-01
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01252208
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2-s2.0-84855539924
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.94, No.10 (2011), 1260-1266
Suggested Citation
Somruedee Chatsiricharoenkul, Weerawon Thangboonjit, Piyapat Pongnarin, Kanitta Konhan, Korbtham Sathirakul, Supornchai Kongpatanakul Bioequivalence Study of 10 mg Ramipril Tablets in Healthy Thai Volunteers. Journal of the Medical Association of Thailand. Vol.94, No.10 (2011), 1260-1266. Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/12277
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Title
Bioequivalence Study of 10 mg Ramipril Tablets in Healthy Thai Volunteers
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Abstract
Objective: 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). Material and Method: 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 of the pharmacokinetic parameters were investigated using non-compartmental analysis. Results: 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-∞ 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-∞ were 108.87% (103.00%-115.07%), 104.93% (100.50%-109.55%) and 103.30% (98.03%-108.85%), respectively. Conclusion: 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.