Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

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∞.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nobelpharma
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Mestranol; Norethindrone; Norethindrone acetate; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Healthy female aged between 20 to 35 years

• BMI:18.0-26.0

Exclusion Criteria:

• Females who are pregnant

• Drug use affecting sex hormone secretion