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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: NPC-01

• Registration Number: NCT01246791
• Lead Sponsor: Nobelpharma

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

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2014-04-10
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPC-01	NPC-01	Single oral administration of NPC-01

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of norethisterone that are active substances of NPC-01.
Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of ethinyl estradiol that are active substances of NPC-01.
Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of norethisterone that are active substances of NPC-01.
Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of ethinyl estradiol that are active substances of NPC-01.
Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of norethisterone that are active substances of NPC-01.
Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of ethinyl estradiol that are active substances of NPC-01.
Plasma Half Life (t1/2) on Norethisterone of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of norethisterone that are active substances of NPC-01.
Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of ethinyl estradiol that are active substances of NPC-01.
Mean Residence Time (MRT) on Norethisterone of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of norethisterone that are active substances of NPC-01.
Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of ethinyl estradiol that are active substances of NPC-01.
Elimination Rate Constant (Kel) on Norethisterone of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of norethisterone that are active substances of NPC-01.
Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01	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	Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of ethinyl estradiol that are active substances of NPC-01.