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A Pivotal Bioequivalence Study of 250 Mcg NGM/25 Mcg EE With or Without Folic Acid in Healthy Female Subjects
The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 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/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | 2005-04 |
| Completion | 2005-08 |
Conditions
- Pharmacokinetics
- Therapeutic Equivalency
- Contraceptives, Oral
Interventions
- Norgestimate; Ethinyl Estradiol; Folic acid.
Primary outcomes
- Determine the bioequivalence of NGM (as measured by the pharmacokinetics of its active breakdown product NGMN) and EE in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.