Overview

A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by dry process, in healthy women.
Phase:
Phase 1
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Moxifloxacin
Norgestimate
Norgestimate, ethinyl estradiol drug combination
Norgestrel
Polyestradiol phosphate