Randomized, open-label, two-way crossover bioequivalence study of Novirax (Drug International Ltd, Bangladesh) compared with Zovirax (Glaxo Wellcome, UK) – two brands of Acyclovir – in healthy male volunteers

  • Uttam Kumar Sarker Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh
  • Mezbah Hossain Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh
  • Md. Atikul Islam Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh
  • Md. Shamsuzzoha Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh
  • Md. Najim Uddin Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh
  • Mir Misbahuddin Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Md. Elias Mollah Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.
  • Md. Rabiul Islam Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.

Abstract

Objectives: A crossover-randomized bioequivalence study of two oral formulations of acyclovir 200 mg tablet was accomplished with 16 adults and physically fit male volunteers from Bangladesh. NOVIRAX™ (Drug International Ltd, Bangladesh) was the test variant whereas ZOVIRAX™ (GlaxoWellcome) was the reference one.


Methods: After a night fasting each volunteer was subjected to take a single dosage of tablet with 150 mL of water. After a week for complete washing out, a second dosage was applied. After that, blood samples were collected at a serial interval for a 24 hours period to observe the plasma concentration by HPLC technique. Several pharmacokinetic parameters like Cmax, Tmax, AUC0→24h, t1/2, and Kel were estimated.


Results: The mean (± SD) AUC0→24h for acyclovir of test variant NOVIRAXTM for 16 participants was 1057.5 ± 358.9 ng/hr/mL whereas it was 1134.9 ± 467.2 ng/hr/mL for acyclovir of ZOVIRAXTM. The relative bioavailability (NOVIRAXTM/ZOVIRAXTM ratio) was 93.2%. The Cmax, tmax, half-life of elimination (t1/2) and the rate of elimination (Kel) of acyclovir of test drug were 207.0 ± 86.9 ng/mL, 2.4 ± 0.4 hours, 3.2 ± 1.8 hour and 0.0898 respectively. The Cmax, tmax, half-life of elimination (t1/2) and the rate of elimination (Kel) of acyclovir of reference drug were 230.7 ± 107.2 ng/mL, 2.0 ± 0.9 hours, 2.8 ± 1.2 hour and 0.0921 respectively.


Conclusion: Depend on these statistical speculations; it was culminated that a NOVIRAX tablet is bioequivalent to a ZOVIRAX tablet.


 

Keywords: Bioequivalence, Acyclovir, HPLC, Pharmacokinetics, Drug International Ltd.

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Author Biographies

Uttam Kumar Sarker, Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Mezbah Hossain, Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Md. Atikul Islam, Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Md. Shamsuzzoha, Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur,Bangladesh

Md. Najim Uddin, Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Department of Chemistry, Hajee Mohammad Danesh Science and Technology University, Dinajpur, Bangladesh

Mir Misbahuddin, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Md. Elias Mollah, Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.

Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.

Md. Rabiul Islam, Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.

Department of Chemistry, Jahangirnagar University, Savar, Dhaka, Bangladesh.

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How to Cite
Sarker, U., Hossain, M., Islam, M., Shamsuzzoha, M., Najim Uddin, M., Misbahuddin, M., Mollah, M., & Islam, M. (2021). Randomized, open-label, two-way crossover bioequivalence study of Novirax (Drug International Ltd, Bangladesh) compared with Zovirax (Glaxo Wellcome, UK) – two brands of Acyclovir – in healthy male volunteers. Asian Journal of Pharmaceutical Research and Development, 9(3), 6-10. https://doi.org/https://doi.org/10.22270/ajprd.v9i3.964