Clinical trial NCT01246791: Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Official title: A Single Dose Pharmacokinetics Study of NPC-01 (1mg Norethisterone and 0.02mg Ethynyl Estradiol) in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: NPC-01
Pharmacokinetics
Healthy female volunteer
Norethisterone
Ethinyl Estradiol
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2010-11-23
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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∞.


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

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Plasma Half Life (t1/2) on Norethisterone of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Mean Residence Time (MRT) on Norethisterone of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Elimination Rate Constant (Kel) on Norethisterone of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
measure: Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01
timeFrame: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hyogo Prefectural AWAJI Hospital
name: Takefumi Matuo, MD
role: PRINCIPAL_INVESTIGATOR
References: