Bioequivalence Study of Two Commercial Products of 3mg Dinoprostone Vaginal Tablets – Pages 277-282

Bioequivalence Study of Two Commercial Products of 3mg Dinoprostone Vaginal Tablets

Pages 277-282

Haleema Yasmin1, Ghazala Ishrat2, Ghousia Saba3, Sohaib Yahya3, Najia Mansoor4 and Mohsin Ali5

1Department of Gynaecology, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan; 2Department of Pharmaceutics, Faculty of Pharmacy, Barrett Hodgson University, Karachi, Pakistan; 3Pharma Professional Services, A-93 Ettawah Society, Scheme 33, Karachi 75340, Pakistan; 4Department of Pharmaceutics, Faculty of Pharmacy, Barrett Hodgson University, Karachi, Pakistan; 5Department of Chemistry, Faculty of Sciences, University of Karachi, Karachi-75270, Pakistan

https://doi.org/10.6000/1927-5129.2018.14.43

Abstract: A randomized, parallel, active control, in vivo bioequivalence study (with clinical endpoint) determining the bioequivalence of two brands of dinoprostone 3 mg vaginal tablets was conducted in pregnant women at Jinnah Postgraduate Medical Center, Karachi. 3mg Dinoprostone vaginal tablet was administered with a second dose repeated after six hours if clinically prescribed. The bioequivalence was assessed by clinical endpoints and a safety analysis was also conducted for all dosed subjects. Maternal bishop score, CTG and neonatal APGAR score were noted. 90% Confidence Intervals for per protocol population was found well within the ±0.20 range. Test product (Glandin E2) and reference product (prostin E2) were found to be bioequivalent.

Keywords: APGAR score, Bioequivalence, Bishop score, CTG, Dinoprostone, prostaglandin, PGE2.