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Bioequivalence Study of an Oral Contraceptive Containing ethinylestradiol/drospirenone/levomefolate Calcium Relative to ethinylestradiol/drospirenone and to Levomefolate Calcium Alone

Bioequivalence Study of an Oral Contraceptive Containing ethinylestradiol/drospirenone/levomefolate Calcium Relative to ethinylestradiol/drospirenone and to Levomefolate Calcium Alone

Hartmut Blode, Christine Klipping, Frank Richard, Dietmar Trummer, Beate Rohde, Konstanze Diefenbach

Contraception. 2012 Feb;85(2):177-84.

PMID: 22067789

Abstract:

Background:
A new tablet formulation containing 0.02 mg ethinylestradiol/3 mg drospirenone/0.451 mg levomefolate calcium (calcium salt containing 0.416 mg L-5-methyltetrahydrofolate) was assessed for bioequivalence compared to the approved oral contraceptive (OC) tablet containing identical amounts of ethinylestradiol and drospirenone and to a tablet containing 0.451 mg levomefolate calcium.
Study design:
Forty-four subjects received in an intraindividual crossover design single doses of the new tablet formulation or the established ethinylestradiol/drospirenone tablet or the levomefolate calcium tablet.
Results:
Bioequivalence was demonstrated for ethinylestradiol, drospirenone and L-5-methyltetrahydrofolate (active moiety of levomefolate calcium) between the investigated tablet formulations. The geometric mean ratios of the AUC((0-tlast)) and C(max) values for all three compounds and their 90% confidence intervals were well within the 80%-125% range generally accepted to demonstrate bioequivalence.
Conclusion:
The rate and extent of absorption of ethinylestradiol and drospirenone were not affected by the concomitant administration of levomefolate calcium and vice versa.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP26560383	Calcium D,L-5-methyltetrahydrofolate		26560-38-3	Price

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