Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT03193307
The primary objective of this trial is to investigate the effect of multiple doses of ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306 and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of ethinylestradiol / levonorgestrel (Microgynon®)
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Notify Me19 year–40 year
Female
Interventional
Phase 1
Seoul, 03080, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
;be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea
Exclusion criteria
Run in period & Treatment Period
Day 18 & 29 (Treatment Period)
Time frame: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Time frame: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
Cmax, maximum measured concentration of BI 409306 in plasma is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
AUC0-24,ss, area under the concentration-time curve of the ethinylestradiol in plasma over the time interval from 0 to 24 hour at steady state.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
AUC0-24,ss, area under the concentration-time curve of the levonorgestrel in plasma over the time interval from 0 to 24 hour at steady state.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Cmax,ss, maximum measured concentration of ethinylestradiol in plasma at steady state is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Cmax,ss, maximum measured concentration of levonorgestrel in plasma at steady state is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Time frame: PK samples were collected 10 min pre-dose and up to 72h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
AUC0-infinity, area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of 1 tablet of 25 mg BI 409306 alone (Day 29).
Boehringer Ingelheim
Industry
A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of Ethinylestradiol/Levonorgestrel (Microgynon®) and BI 409306 in Healthy Korean Premenopausal Female Subjects (an Open-label, Two-period, Fixed-sequence Study)
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