Conditions: Healthy
Keywords: NPC-01 Pharmacokinetics Healthy female volunteer Norethisterone Ethinyl Estradiol
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.

Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.

Detailed description:

Arms:
arm 1: Single oral administration of NPC-01

Interventions: intervention 1: NPC-01
Intervention descriptions: intervention 1: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition

Protocol document: