NCT01253174 - Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

July 31, 2007

Study Completion Date

July 31, 2007

Conditions

Contraception

Interventions

DRUG

EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)

single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)

DRUG

EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)

single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin

DRUG

L-5-MTHF Ca 0.451 mg (Metafolin)

single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin

Trial Locations (1)

22525

Scope International, Hamburg