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Dose Response. 2018 Jul 25;16(3):1559325818783932. doi: 10.1177/1559325818783932. eCollection 2018.

Pharmacokinetics and Bioavailability Study of a Prednisolone Tablet as a Single Oral Dose in Bangladeshi Healthy Volunteers.

Dose-response : a publication of International Hormesis Society

Tafsir Bashar, Mohd Nazmul Hasan Apu, Md Shaki Mostaid, Md Saiful Islam, Abul Hasnat

Affiliations

  1. Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka, Bangladesh.

PMID: 30083083 PMCID: PMC6073839 DOI: 10.1177/1559325818783932

Abstract

The aim of the study was to assess the pharmacokinetic and bioavailability of 2 formulations of 5-mg prednisolone tablets, reference product (Teva UK Limited) and Pred (Eskayef Bangladesh Ltd) as test product. The open-label, randomized, 2-way crossover studies were conducted on 14 healthy subjects. Participants were assigned to receive both products as a single dose (20 mg formulations, 4 × 5 mg tablets) followed by a 2 weeks' washout period. Following oral administration, samples were obtained at various time intervals and analyzed for prednisolone concentrations using a validated high-performance liquid chromatography assay method with ultraviolet detection. The obtained values for test and reference products were 683.00 ± 94.54 ng/mL and 635.16 ± 125.57 ng/mL for C

Keywords: Bangladeshi healthy volunteers.; bioavailability; bioequivalence; pharmacokinetics; prednisolone

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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