Comparative Bioavailability Study of Two Ramipril Tablet
Formulations in Indonesian Healthy Volunteers |
| Yahdiana Harahap1, Lucy Sasongko2, Budi Prasaja3*,
Windy Lusthom3, Evy C. Setiawan3, Raria S. Meliala3, Lipin3 |
| 1Department of Pharmacy, Faculty of Mathematic and Science, University of Indonesia, Depok (Indonesia) |
| 2School of Pharmacy, Bandung Institute of Technology, Bandung (Indonesia) |
| 3Clinisindo Laboratories, Jakarta (Indonesia) |
| *Corresponding author: |
Dr. Budi Prasaja, S.Si., Apt, MM,
Clinisindo Laboratories,
Jl. Ulujami Raya 12, Jakarta 12250 (Indonesia),
Tel : +622173889918,
Fax : +6221 73885453,
E-mail :budi.prasaja@clinisindo.com |
|
| Received November 05, 2009; Accepted December 13, 2009; Published
December 13, 2009 |
Citation: Harahap Y, Sasongko L, Prasaja B, Lusthom W, Setiawan
EC, et al. (2009) Comparative Bioavailability Study of Two Ramipril Tablet
Formulations in Indonesian Healthy Volunteers. J Bioanal Biomed 1:
017-021. doi:10.4172/1948-593X.1000004 |
|
Copyright:© 2009 Harahap Y, et al. This is an open-access article
distributed under the terms of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are credited. |
Abstract |
Aim
To compare the bioavailability of two ramipril tablet formulations– 10 mg Prohytens® tablets as test formulation
and 10 mg Triatec® tablets as reference formulation.
Methods
A single-dosed, open-label, randomized two-way crossover
design under fasting period with two weeks wash
out period was evaluated in 24 subjects. For the analysis
of pharmacokinetic properties, the blood samples were
drawn taken up to 72 hours after dosing. Plasma concentration
of ramipril and ramiprilat were determined using
liquid chromatography – tandem mass spectrometry
method with TurboIonSpray mode. Pharmacokinetic parameters
AUC0-t, AUC0-∞ and Cmax were tested for
bioequivalence after log-transformation of data and ratios
of tmax were evaluated non-parametrically.
Results
The point estimates and 90% confidence intervals (CI)
for AUC0-t, AUC0-∞ and Cmax for ramipril were 93.21%
(85.67-101.41%), 93.45% (85.88-101.69%), 94.02%
(80.09-110.38%) and for ramiprilat were 92.26% (87.76-
96.99%), 94.59% (89.71-99.73%) and 91.55% (84.88-
98.74%).
Conclusion
These results indicated that the two formulations of
ramipril were bioequivalent and thus may be prescribed
interchangeably. |
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