Bioequivalence study of an oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium relative to ethinylestradiol/drospirenone and to levomefolate calcium alone
| Autor: | Beate Rohde, Hartmut Blode, Dietmar Trummer, Frank Richard, Konstanze Diefenbach, Christine Klipping |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Adolescent Cmax chemistry.chemical_element Calcium Pharmacology Bioequivalence Ethinyl Estradiol Bioequivalence study Young Adult Glutamates Ethinylestradiol Humans Medicine Mineralocorticoid Receptor Antagonists Cross-Over Studies business.industry Obstetrics and Gynecology Estrogens Drospirenone Crossover study Contraceptives Oral Combined Therapeutic Equivalency Reproductive Medicine chemistry Androstenes Female business Levomefolate calcium medicine.drug |
| Zdroj: | Contraception. 85:177-184 |
| ISSN: | 0010-7824 |
| DOI: | 10.1016/j.contraception.2011.05.015 |
| Popis: | 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 Cmax 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect