[The relative pharmacokinetics of two oral formulations of chlormadinone acetate: Lutéran 5mg. and Lutéran tablet 10 mg].
The bioavailability of a new formulation of chlormadinone acetate (one 10 mg Lutéran tablet) was compared with that of the reference formulation (two 5 mg Lutéran tablets) in a randomised crossover open trial after single oral administration of a 10 mg dose to 12 healthy female volunteers. Measurements of chlormadinone acetate plasma samples were performed by combined gas chromatography/mass spectrometry. Blood samples were collected before administration and up to 144 hours after administration. No significant difference was found between the two formulations in pharmacokinetic parameters. The bioavailability of the two formulations was equivalent in terms of time to maximum concentration (tmax [mean tmax about 2.5 h]) and area under the concentration-time curve (AUC0-infinity) [Weslake's symmetric confidence interval: 19.24%, Schuirmann two one-sided tests procedure: p < 0.05]. No difference was found between the two formulations with regard to clinical safety parameters.
Chassard
Didier
D
Laboratoire Aventis, Paris, France.
Legallicier
Pascale
P
Dib
Michel
M
D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002715:Chlormadinone Acetate / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D013607:Tablets
D003278:Contraceptives, Oral, Hormonal; D013607:Tablets; D002715:Chlormadinone Acetate