Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.

• Status: Completed
• Trial end date: 2005-08-01

Summary

The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.

• Phase: Phase 1

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Folic Acid; Norgestimate; Norgestrel; Polyestradiol phosphate; Vitamin B Complex