Randomized, Open-Label, Two-Way Crossover Study to Compare the Bioequivalence of PRELIN™ and LYRICA™ Among Bangladeshi Male Volunteers

Authors

  • Uttam Kumar Sarker Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur;
  • Mst. Fakid Sharmin Sristy Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur;
  • Fatiha Farhana Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur;
  • Sorotoshini Haque Uttsha Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur;
  • Balaram Roy Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur;
  • Mir Misbahuddin Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka;
  • Md. Elias Mollah Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.
  • Md. Rabiul Islam  Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.

DOI:

https://doi.org/10.22270/ajprd.v14i3.1838

Abstract

Background: Pregabalin, an anticonvulsant and neuropathic pain agent, acts by binding to the α2δ subunit of voltage-gated calcium channels, reducing neurotransmitter release. It is commonly prescribed for epilepsy, generalized anxiety disorder, and fibromyalgia. Assessing bioequivalence between generic and branded formulations is critical to ensure consistent therapeutic effects.

Objective: This study aimed to compare the bioequivalence of two 150 mg oral pregabalin capsules PRELIN™ (Drug International Ltd., Bangladesh) as the test product and LYRICA™ (Pfizer Laboratories) as the reference in healthy Bangladeshi male subjects.

Methods: A randomized, two-period, two-sequence crossover study was conducted in 16 healthy male volunteers. Each participant received a single 150 mg dose of either formulation after fasting, with a washout period of over one week between treatments. Plasma pregabalin levels were measured over 24 hours using validated LC-MS/MS. Key pharmacokinetic parameters (Cmax, Tmax, AUC₀–₂₄h, t½, and Kel) were calculated using non-compartmental analysis.

Results: The mean AUC₀–₂₄h was 105.0 ± 32.8 ng·h/mL for PRELIN™ and 126.9 ± 40.0 ng·h/mL for LYRICA™, indicating a relative bioavailability of 82.7%. Cmax values were 36.2 ± 10.4 ng/mL (PRELIN™) and 40.3 ± 9.4 ng/mL (LYRICA™), while Tmaxwas 1.4 ± 0.7 hours and 1.1 ± 0.3 hours, respectively. Elimination half-life was 4.6 ± 1.6 hours for PRELIN™ and 4.1 ± 3.6 hours for LYRICA™, with corresponding Kel values of 0.1642 h⁻¹ and 0.0975 h⁻¹.

Conclusion: PRELIN™ exhibited pharmacokinetic parameters similar to LYRICA™, although its relative bioavailability was slightly below the standard bioequivalence threshold. Nonetheless, both formulations showed comparable absorption profiles.

 

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Published

2026-06-19 — Updated on 2026-07-28

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How to Cite

Uttam Kumar Sarker, Mst. Fakid Sharmin Sristy, Fatiha Farhana, Sorotoshini Haque Uttsha, Balaram Roy, Mir Misbahuddin, … Md. Rabiul Islam. (2026). Randomized, Open-Label, Two-Way Crossover Study to Compare the Bioequivalence of PRELIN™ and LYRICA™ Among Bangladeshi Male Volunteers. Asian Journal of Pharmaceutical Research and Development, 14(3), 432–437. https://doi.org/10.22270/ajprd.v14i3.1838 (Original work published June 19, 2026)

Issue

Vol. 14 No. 3 (2026): Volume 14 Issue 3 May - June 2026

Section

Research Articles

Copyright (c) 2026 Uttam Kumar Sarker, Mst. Fakid Sharmin Sristy, Fatiha Farhana, Sorotoshini Haque Uttsha, Balaram Roy, Mir Misbahuddin, Md. Elias Mollah, Md. Rabiul Islam

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