NCT01246791

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∞.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_3 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 17, 2014

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

November 18, 2010

Results QC Date

April 10, 2014

Last Update Submit

June 3, 2025

Conditions

Healthy

Keywords

NPC-01PharmacokineticsHealthy female volunteerNorethisteroneEthinyl Estradiol

Outcome Measures

Primary Outcomes (12)

  • Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone 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.

    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

  • Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol 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.

    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

  • Peak Plasma Concentration (Cmax) on Norethisterone 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.

    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

  • Peak Plasma Concentration (Cmax) on Ethinyl Estradiol 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.

    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

  • Time to Peak Plasma Concentration (Tmax) on Norethisterone 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.

    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

  • Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol 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.

    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

  • Plasma Half Life (t1/2) on Norethisterone 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.

    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

  • Plasma Half Life (t1/2) on Ethinyl Estradiol 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.

    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

  • Mean Residence Time (MRT) on Norethisterone 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.

    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

  • Mean Residence Time (MRT) on Ethinyl Estradiol 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.

    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

  • Elimination Rate Constant (Kel) on Norethisterone 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.

    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

  • Elimination Rate Constant (Kel) on Ethinyl Estradiol 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.

    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

Study Arms (1)

NPC-01

EXPERIMENTAL

Single oral administration of NPC-01

Drug: NPC-01

Interventions

NPC-01DRUG

NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition

Also known as: Norethisterone and Ethinyl Estradiol
NPC-01

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female aged between 20 to 35 years
  • BMI:18.0-26.0

You may not qualify if:

  • Females who are pregnant
  • Drug use affecting sex hormone secretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

NorethindroneEthinyl Estradiol

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Department director of clinical development department 1
Organization
Nobelpharma
murakami@nobelpharma.co.jp
+81-3-5651-1177

Study Officials

  • Takefumi Matuo, MD

    Hyogo Prefectural AWAJI Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 23, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 17, 2025

Results First Posted

June 17, 2014

Record last verified: 2025-06