An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg EE (ORTHO-CYCLEN) in Healthy Women..

NCT00709982 Phase 1 COMPLETED

The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate\[NGM\]/35 mcg Ethinyl Estradiol \[EE\]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined.

Details

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 1
Status	COMPLETED
Enrolment	47
Start date	2005-05
Completion	2005-07

Conditions

• Drug Interactions
• Healthy
• Pharmacokinetics

Interventions

• Norgestimate; Ethinyl Estradiol; Folic acid

Primary outcomes

• Evaluate the pharmacokinetic drug interaction between folic acid and the study drug (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown product of NGM, norelgestromin (NGMN), and EE.