NCT05282940View on ClinicalTrials.gov

Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 26, 2022

Primary Completion Date

March 15, 2022

Study Completion Date

April 8, 2022

Conditions
Therapeutic Equivalency
Interventions
DRUG

Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug

Investigational Medicinal Product

DRUG

Microgynon CD

Microgynon CD will be used as a comparator drug for the BE study. Other Name: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Drug

Trial Locations (1)

600048

Azidus Laboratories Ltd., Chennai

Sponsors
All Listed Sponsors
lead

Laboratorios Andromaco S.A.

INDUSTRY

NCT05282940 - Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product | Biotech Hunter | Biotech Hunter