title: Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women.
abstract: BACKGROUND
  The progestin dienogest was developed for oral contraception, endometriosis treatment and menopause management. Dienogest's pharmacokinetics have been primarily studied in Caucasian women. This study evaluated the single- and multiple-dose pharmacokinetics of dienogest in Korean women.
  
  
  METHODS
  Sixteen healthy Korean adult women received a single administration of 2 mg dienogest, followed by multiple once-daily administrations for 14 days. The single-dose administration and the final dose of the multiple administrations were each followed by blood sampling over 60 h.
  
  
  RESULTS
  The mean (SD) maximum serum concentration after multiple doses of dienogest was slightly increased compared with that after a single dose [from 51.6 (9.6) to 56.6 (11.9) ng/mL], as was the area under the concentration-time curves (AUC)0-24h [from 503 (56.3) to 613 (90.7) ng ∙ h/mL]. The linearity factor calculated by AUCs of single and multiple doses is 1.00 ± 0.14, and the terminal half-life remained unchanged when single dosing and multiple dosing were compared.
  
  
  CONCLUSIONS
  The present study described the single- and multiple-dose pharmacokinetic profiles of dienogest in Korean women and showed linear pharmacokinetics of dienogest at steady state.
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 110-744, Korea.
authors.forename: Donghoon
authors.initials: D
authors.lastname: Shin
authors.forename: SeungHwan
authors.initials: S
authors.lastname: Lee
authors.forename: Kyoung Soo
authors.initials: KS
authors.lastname: Lim
authors.forename: Joong Shin
authors.initials: JS
authors.lastname: Park
authors.forename: Sang-Goo
authors.initials: SG
authors.lastname: Shin
authors.forename: In-Jin
authors.initials: IJ
authors.lastname: Jang
authors.forename: Kyung-Sang
authors.initials: KS
authors.lastname: Yu
mesh_terms: D000284:Administration, Oral; D000328:Adult; D003276:Contraceptives, Oral / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006207:Half-Life; D006801:Humans; D008657:Metabolic Clearance Rate; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D011372:Progestins / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D056910:Republic of Korea; D013607:Tablets; D055815:Young Adult
chemical_list: D003276:Contraceptives, Oral; D011372:Progestins; D013607:Tablets; C023635:dienogest; D009277:Nandrolone