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

Authors

  • Haleema Yasmin Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan
  • Ghazala Ishrat Faculty of Pharmacy, Barrett Hodgson University, Karachi, Pakistan
  • Ghousia Saba Pharma Professional Services, A-93 Ettawah Society, Scheme 33, Karachi 75340, Pakistan
  • Sohaib Yahya Pharma Professional Services, A-93 Ettawah Society, Scheme 33, Karachi 75340, Pakistan
  • Najia Mansoor Faculty of Pharmacy, Barrett Hodgson University, Karachi, Pakistan
  • Mohsin Ali Faculty of Sciences, University of Karachi, Karachi-75270, Pakistan

DOI:

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

Keywords:

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

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.

References

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Published

2018-01-05

How to Cite

Haleema Yasmin, Ghazala Ishrat, Ghousia Saba, Sohaib Yahya, Najia Mansoor, & Mohsin Ali. (2018). Bioequivalence Study of Two Commercial Products of 3mg Dinoprostone Vaginal Tablets. Journal of Basic & Applied Sciences, 14, 277–282. https://doi.org/10.6000/1927-5129.2018.14.43

Issue

Section

Pharmaceutical Sciences