Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects
Abstract
Yahdiana Harahap, Vincentia Prasetyo, Monika Sandra, Tri Rahayu, Windy Lusthom, Budi Prasaja
This study aimed to compare the bioavailability of two 10-mg Imidapril HCl tablet formulations using TENSIMID® as the test formulation and TANAPRESS® as the reference formulation. Twenty-seven healthy subjects completed a single-dosed, open-label, randomized, two-way crossover bioequivalence study under overnight fasting condition with one week wash-out period. The blood samples were collected from the subjects prior to administration and up to 12 hours after dosing. Plasma concentrations of imidapril were determined using LC-MS/MS method with TurboIon Spray mode. Pharmacokinetic parameters of AUC0-t, AUC0-âˆ�and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax was evaluated non-parametrically. The estimated points and 90% confidence interval (CI) for AUC0-t, AUC0-âˆ�and Cmax of imidapril were 93.04% (82.63-104.76%), 93.12% (82.84-104.67%), and 94.00% (80.96-109.14%), respectively. There was no statistically significant difference of tmax and t1/2 detected in both formulations (p<0.05). The result indicated that the two formulations of imidapril were bioequivalent and thus may be prescribed interchangeably.
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| Pubmed Style Harahap Y, Prasetyo V, Sandra M, Rahayu T, Lusthom W, Prasaja B. Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. SRP. 2021; 12(1): 1540-1544. doi:10.31838/srp.2021.1.216 Web Style Harahap Y, Prasetyo V, Sandra M, Rahayu T, Lusthom W, Prasaja B. Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. http://www.sysrevpharm.org/?mno=52361 [Access: March 30, 2021]. doi:10.31838/srp.2021.1.216 AMA (American Medical Association) Style Harahap Y, Prasetyo V, Sandra M, Rahayu T, Lusthom W, Prasaja B. Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. SRP. 2021; 12(1): 1540-1544. doi:10.31838/srp.2021.1.216 Vancouver/ICMJE Style Harahap Y, Prasetyo V, Sandra M, Rahayu T, Lusthom W, Prasaja B. Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. SRP. (2021), [cited March 30, 2021]; 12(1): 1540-1544. doi:10.31838/srp.2021.1.216 Harvard Style Harahap, Y., Prasetyo, . V., Sandra, . M., Rahayu, . T., Lusthom, . W. & Prasaja, . B. (2021) Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. SRP, 12 (1), 1540-1544. doi:10.31838/srp.2021.1.216 Turabian Style Harahap, Yahdiana, Vincentia Prasetyo, Monika Sandra, Tri Rahayu, Windy Lusthom, and Budi Prasaja. 2021. Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. Systematic Reviews in Pharmacy, 12 (1), 1540-1544. doi:10.31838/srp.2021.1.216 Chicago Style Harahap, Yahdiana, Vincentia Prasetyo, Monika Sandra, Tri Rahayu, Windy Lusthom, and Budi Prasaja. "Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects." Systematic Reviews in Pharmacy 12 (2021), 1540-1544. doi:10.31838/srp.2021.1.216 MLA (The Modern Language Association) Style Harahap, Yahdiana, Vincentia Prasetyo, Monika Sandra, Tri Rahayu, Windy Lusthom, and Budi Prasaja. "Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects." Systematic Reviews in Pharmacy 12.1 (2021), 1540-1544. Print. doi:10.31838/srp.2021.1.216 APA (American Psychological Association) Style Harahap, Y., Prasetyo, . V., Sandra, . M., Rahayu, . T., Lusthom, . W. & Prasaja, . B. (2021) Comparative Bioavailability Study of Two Imidapril Tablet Formulations in Indonesian Healthy Subjects. Systematic Reviews in Pharmacy, 12 (1), 1540-1544. doi:10.31838/srp.2021.1.216 |
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