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

NCT ID: NCT01246791

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

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∞.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPC-01

Single oral administration of NPC-01

Group Type: EXPERIMENTAL

NPC-01

Intervention Type: DRUG

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

Interventions

NPC-01

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

Intervention Type: DRUG

Other Intervention Names

Norethisterone and Ethinyl Estradiol

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takefumi Matuo, MD

Role: PRINCIPAL_INVESTIGATOR

Hyogo Prefectural AWAJI Hospital

Other Identifiers

NPC-01-3

Identifier Type: -

Identifier Source: org_study_id