Phase 3
N=12
Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01246791 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01 — 69.183 ng･hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NPC-01 (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Nobelpharma
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01 |
69.183 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01 |
368.123 | — |
| PRIMARY Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01 |
12.481 | — |
| PRIMARY Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01 |
55.783 | — |
| PRIMARY Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01 |
1.81 | — |
| PRIMARY Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01 |
1.50 | — |
| PRIMARY Plasma Half Life (t1/2) on Norethisterone of NPC-01 |
7.357 | — |
| PRIMARY Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01 |
5.499 | — |
| PRIMARY Mean Residence Time (MRT) on Norethisterone of NPC-01 |
6.340 | — |
| PRIMARY Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01 |
5.161 | — |
| PRIMARY Elimination Rate Constant (Kel) on Norethisterone of NPC-01 |
0.101 | — |
| PRIMARY Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01 |
0.141 | — |
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∞.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01246791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.