NCT02127593View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Healthy
Interventions
DRUG

Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)

Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by wet process will be orally administered on Day 1 of Period 1 or Period 2.

DRUG

Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)

Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by dry process will be orally administered on Day 1 of Period 1 or Period 2.

Trial Locations (1)

Unknown

Groningen

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02127593 - A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities | Biotech Hunter | Biotech Hunter