Bioequivalence Study of Cyclizine Hydrochloride 50 Mg Tablets in Healthy volunteers: a randomized, open-label, single-dose Study

Abstract

Background: Cyclizine is used in the treatment and prevention of nausea and vomiting. We aimed to demonstrate bioequivalence between two formulations of cyclizine 50 mg tablets. Methods/Results: This single-dose, two-treatment, two-period, two-sequence, open-label, randomized crossover study was conducted on 32 healthy male volunteers. The average values for C_max, T_max, AUC_0-t and AUC_0-inf were 21.50 ng/ml, 3.85 h, 423.71 ng.h/ml and 489.26 ng.h/ml, for cyclizine 50 mg (test) versus 20.39 ng/ml, 4.34 h, 410.56 ng.h/ml and 473.86 ng.h/ml for Valoid 50 mg (reference). The 90% CI of the mean ratios of C_max (geometric mean ratio: 101.81 ng/ml), and AUC_0-t (101.81 ng.h/ml) were within the bioequivalence range of 80 to 125%. Both drugs were well tolerated. Conclusion: Cyclizine 50 mg is bioequivalent to the reference.

Keywords:

• bioequivalence
• cyclizine
• pharmacokinetics

Acknowledgements

The authors thank all the volunteers for participating in the study. The authors thank Accutest Research Laboratories (I) Pvt. Ltd (Clinical laboratory and statistical facility), Sitec Labs Pvt. Limited (Bioanalytical facility) and their personnel for their support in conducting the study.

Ethical conduct of research

This study was conducted in accordance with ethical principles embodied in the Declaration of Helsinki, the ICH-GCP guidelines, and the note for guidance on investigation of bioavailability and bioequivalence laid down by the European Agency for the Evaluation of Medicinal Products.

Financial & competing interests disclosure

This study was sponsored by Cipla Ltd (India). All the authors are employees of Cipla Limited, India. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.