Volume 2 Issue 1
Research Article: Bioequivalence of Two Oral-Suspension Formulations of Oseltamivir in Healthy Mexican Adults
Araceli G Medina-Nolasco1, Karina L Ortiz-Campos1, Ericka Lopez-Bojorquez2, Liliana Zazueta-Beltran2, Victoria Burke-Fraga2 and Mario Gonzalez-de la Parra2*
Oseltamivir is an oral prodrug of oseltamivir carboxylate, which is a selective inhibitor of influenza A and B neuraminidases. It is indicated for the treatment and prophylaxis of influenza A and B infections. In this study, we investigated the bioavailability and the bioequivalence of a test oral-suspension oseltamivir formulation (6 mg/ mL) with respect to the corresponding reference oral-suspension formulation. A single-dose randomized, open-label, two treatment, two-sequence, two-period crossover design under fasting conditions with a 4-day washout interval between the two periods was used.
A single dose of 75 mg of oseltamivir (in 12.5 mL of oral suspension) was administered to healthy adult Mexican subjects.
Samples were drawn at baseline and then at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00 and 12.00 hours after administration.
The 90% CIs for oseltamivir Cmax, AUC0-t and AUC0-8 were 98.34%-114.47%, 95.27%-100.49% and 95.93%-101.10%, respectively, which fell within the predetermined range of 80% to 125%. Thus, these results show that the bioequivalence criteria were met.
Keywords: Oseltamivir; Suspension; Bioavailability; Bioequivalence
Cite this Article: Medina-Nolasco AG, Ortiz-Campos KL, Lopez-Bojorquez E, Zazueta-Beltran L, Gonzalez-de la Parra M, et al. Bioequivalence of Two Oral-Suspension Formulations of Oseltamivir in Healthy Mexican Adults. Am J Pharmacol Ther. 2018;2(1): 007-011.
Published: 04 December 2018
Research Article: Bioequivalence, Safety and Tolerability of Sitagliptin 100 mg and Metformin Hydrochloride 1000 mg Prolonged-Release Tablets in Healthy Adult Volunteers
Vamshi Ramana Prathap, Harikiran Chary Vadla, Balaramesha Chary Rallabandi and Ramesh Gannu*
The objective of the study was to evaluate the bioequivalence, safety and tolerability of a fixed-dose combination formulation, FDC (Sitagliptin 100 mg and Metformin hydrochloride 1000 mg prolonged-release tablets) relative to reference formulations (Januvia® 100 mg Filmtabletten co-administered with Glucophage®; SR 1000 mg Prolonged-release Tablets) after single dose administration under fasted and fed condition in healthy adult male and female volunteers. An open label, two period, two treatment, two-way crossover, randomized study design was utilized for the investigation. Blood samples were collected at scheduled time points till 120 h after drug administration. A wash-out period of 14 days was maintained between two periods. Eight adverse events of mild in severity occurred in five subjects in the study; no serious adverse events reported.
The statistical analysis of the pharmacokinetics indicates that FDC met the bioequivalence criteria under fed state for both drugs. While Sitagliptin was bioequivalent in fasted state and Metformin showed indicative results, possibly could show bioequivalence in adequate number of subjects.
The conclusions drawn from the study indicate that, FDC was tolerable and the adverse events are similar to the reference products and are mild in nature, hence safe to use in human subjects. FDC showed comparable in vivo behavior to that of reference formulations.
Keywords: Sitagliptin; Metformin; Pharmacokinetics; Bioequivalence; Safety; Tolerability
Cite this Article: Vamshi RP, Harikiran CV, Balaramesha CR, Ramesh G. Bioequivalence, Safety and Tolerability of Sitagliptin 100 mg and Metformin Hydrochloride 1000 mg Prolonged-Release Tablets in Healthy Adult Volunteers. Am J Pharmacol Ther. 2018;2(1): 001-006.
Published: 22 September 2018
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