Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01246791 |
Recruitment Status :
Completed
First Posted : November 23, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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∞.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: NPC-01 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246791
Principal Investigator: | Takefumi Matuo, MD | Hyogo Prefectural AWAJI Hospital |
Responsible Party: | Nobelpharma |
ClinicalTrials.gov Identifier: | NCT01246791 |
Other Study ID Numbers: |
NPC-01-3 |
First Posted: | November 23, 2010 Key Record Dates |
Results First Posted: | June 17, 2014 |
Last Update Posted: | June 17, 2014 |
Last Verified: | May 2014 |
NPC-01 Pharmacokinetics Healthy female volunteer Norethisterone Ethinyl Estradiol |
Ethinyl Estradiol Norethindrone Norinyl Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Hormonal Contraceptives, Oral Contraceptives, Oral, Synthetic Contraceptives, Oral, Combined |