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Bioavailability Section

Bioequivalence of two formulations of pregabalin 150-mg capsules under fasting conditions in healthy male subjects 

Hyun Lee, SeungHwan Lee, Sung-Vin Yim, Bo-Hyung Kim

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Volume 55 (2017) p. 171 - 176

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 2/2017 (171-176)

Bioequivalence of two formulations of pregabalin 150-mg capsules under fasting conditions in healthy male subjects 

Hyun Lee¹,², SeungHwan Lee², Sung-Vin Yim³, Bo-Hyung Kim³,⁴ 

¹Program in Biomedical Radiation Sciences, Program in Biomedical Radiation Sciences, Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, ³Department of Clinical Pharmacology and Therapeutics, and ⁴East-West Medical Research Institute, Kyung Hee University College of Medicine and Hospital, Seoul, Korea
Background: Pregabalin binds to the α2δ auxiliary subunit of voltage-gated calcium channels, which are widely distributed throughout the central and peripheral nervous systems and modulate calcium-dependent neurotransmitter release. Pregabalin is indicated for the treatment of peripheral and central neuropathic pain, partial seizures with or without secondary generalization, and treatment of generalized anxiety disorder (GAD). Objective: The purpose of this study was to assess the bioequivalence of two different formulations of pregabalin 150-mg capsules in healthy Korean male subjects under fasting conditions. Methods: This bioequivalence study was based on an open-label, single-dose, randomized, 2-period, 2-sequence crossover design with a washout period of 7 days. Blood samples for pharmacokinetic (PK) evaluation were collected up to 24 hours postdose. Plasma concentrations of pregabalin were determined using a validated LC-MS/MS method. PK parameters were determined using noncompartmental analysis. Bioequivalence was assumed if the 90% confidence intervals (CIs) for the test/reference ratios of log-transformed C_max and AUC_last values met the bioequivalence criteria specified by Korean regulatory guidelines (90% CI 0.8 – 1.25). Results: The extent of exposure in terms of AUC_last amounted to 26,018.3 – 3,580.8 µg×h/L for the test formulation and 25,680.2 ± 3,083.6 µg×h/L for the reference formulation. C_max reached values of 4,782.7 ± 1,124.2 µg/L and 4,654.0 ± 911.4 µg/L for the test product and reference product, respectively. The geometric mean ratio and 90% CIs of the test product to the reference product were 1.0132 (0.9862 – 1.0351) for AUC_last and 1.0153 (0.9351 – 1.1044) for C_max, which were well within the range necessary to establish bioequivalence (90% CI 0.8 – 1.25). Conclusions: The bioequivalence between test and reference formulations under fasting conditions was confirmed both in terms of the rate and extent of absorption. Correspondence to:
Bo-Hyung Kim, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Kyung Hee University College of Medicine and Hospital
23 Kyungheedae-ro, Dongdaemun-gu,
Seoul 130-872, Korea
Email:  [email protected]

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