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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: NPC-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT01246791

NPC-01-3

Details and patient eligibility

About

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∞.

Enrollment: 12 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

NPC-01

Experimental group

Description:

Single oral administration of NPC-01

Treatment:

Drug: NPC-01