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

This study has been completed.
Sponsor:
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT01246791
First received: November 18, 2010
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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 AUCt, Cmax, tmax, t1/2, MRT, kel and AUC∞.


Condition Intervention Phase
Healthy Female
Drug: NPC-01
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose Pharmacokinetics Study of NPC-01 (1mg Norethisterone and 0.02mg Ethynyl Estradiol) in Healthy Female Volunteers

Resource links provided by NLM:


Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of NPC-01 [ Time Frame: Multiple blood samples will be collected for 24 hours after single dosing of NPC-01 ] [ Designated as safety issue: No ]
    Multiple blood samples will obtains for 24 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 each Norethisterone and Ethinyl estradiol that are active substances of NPC-01.

  • Peak plasma concentration (Cmax) of NPC-01 [ Time Frame: Multiple blood samples will be collected for 24 hours after single dosing of NPC-01 ] [ Designated as safety issue: No ]
    Multiple blood samples will obtains for 24 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of each Norethisterone and Ethinyl estradiol that are active substances of NPC-01.

  • Time to peak plasma concentration (Tmax) of NPC-01 [ Time Frame: Multiple blood samples will be collected for 24 hours after single dosing of NPC-01 ] [ Designated as safety issue: No ]
    Multiple blood samples will obtains for 24 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration of each Norethisterone and Ethinyl estradiol that are active substances of NPC-01.

  • Plasma Half life (t1/2) of NPC-01 [ Time Frame: Multiple blood samples will be collected for 24 hours after single dosing of NPC-01 ] [ Designated as safety issue: No ]
    Multiple blood samples will obtains for 24 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of each Norethisterone and Ethinyl estradiol that are active substances of NPC-01.

  • Mean residence time (MRT) of NPC-01 [ Time Frame: Multiple blood samples will be collected for 24 hours after single dosing of NPC-01 ] [ Designated as safety issue: No ]
    Multiple blood samples will obtains for 24 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of Mean residence time (MRT) of each Norethisterone and Ethinyl estradiol that are active substances of NPC-01.

  • Elimination rate constant (kel) of NPC-01 elimination rate constant elimination rate constant [ Time Frame: Multiple blood samples will be collected for 24 hours after single dosing of NPC-01 ] [ Designated as safety issue: No ]
    Multiple blood samples will obtains for 24 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of each Norethisterone and Ethinyl estradiol that are active substances of NPC-01.


Estimated Enrollment: 12
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-01
Single oral administration of NPC-01
Drug: NPC-01
NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
Other Name: Norethisterone and Ethinyl Estradiol

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246791

Sponsors and Collaborators
Nobelpharma
Investigators
Principal Investigator: Takefumi Matuo, MD Hyogo Prefectural AWAJI Hospital
  More Information

No publications provided

Responsible Party: Nobelpharma Co., Ltd. IKH development Group
ClinicalTrials.gov Identifier: NCT01246791     History of Changes
Other Study ID Numbers: NPC-01-3
Study First Received: November 18, 2010
Last Updated: June 7, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:
NPC-01
Pharmacokinetics
Healthy female volunteer
Norethisterone
Ethinyl Estradiol

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Mestranol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone acetate
Norinyl
Ethynylestradiol mixture with norethindrone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential

ClinicalTrials.gov processed this record on April 16, 2014