Trials / Completed
CompletedNCT01246791
Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
A Single Dose Pharmacokinetics Study of NPC-01 (1mg Norethisterone and 0.02mg Ethynyl Estradiol) in Healthy Female Volunteers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Nobelpharma · Industry
- Sex
- Female
- Age
- 20 Years – 35 Years
- Healthy volunteers
- Accepted
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∞.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPC-01 | NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2010-11-23
- Last updated
- 2025-06-17
- Results posted
- 2014-06-17
Source: ClinicalTrials.gov record NCT01246791. Inclusion in this directory is not an endorsement.