title: Bioequivalence study of an oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium relative to ethinylestradiol/drospirenone and to levomefolate calcium alone.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  The rate and extent of absorption of ethinylestradiol and drospirenone were not affected by the concomitant administration of levomefolate calcium and vice versa.
authors: Bayer HealthCare Pharmaceuticals, D-13342 Berlin, Germany. hartmut.blode@bayer.com
authors: Hartmut
authors: H
authors: Blode
authors: Christine
authors: C
authors: Klipping
authors: Frank
authors: F
authors: Richard
authors: Dietmar
authors: D
authors: Trummer
authors: Beate
authors: B
authors: Rohde
authors: Konstanze
authors: K
authors: Diefenbach
mesh_terms: D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D002118:Calcium / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004967:Estrogens; D005971:Glutamates; D000451:Mineralocorticoid Receptor Antagonists; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol; C569381:levomefolate calcium; D002118:Calcium