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Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
This study has been completed.
Sponsor:
Nobelpharma
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT01246791
First received: November 18, 2010
Last updated: May 15, 2014
Last verified: May 2014
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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 AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy | Drug: NPC-01 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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:
Drug Information available for:
Estradiol
Norethindrone acetate
Ethinylestradiol
Norethindrone
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Nobelpharma:
Primary Outcome Measures:
- 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.
| 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 (Adult) |
| Sexes 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
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246791
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
| Responsible Party: | Nobelpharma |
| ClinicalTrials.gov Identifier: | NCT01246791 History of Changes |
| Other Study ID Numbers: |
NPC-01-3 |
| Study First Received: | November 18, 2010 |
| Results First Received: | April 10, 2014 |
| Last Updated: | May 15, 2014 |
Keywords provided by Nobelpharma:
|
NPC-01 Pharmacokinetics Healthy female volunteer Norethisterone Ethinyl Estradiol |
Additional relevant MeSH terms:
|
Ethinyl Estradiol Estradiol Polyestradiol phosphate Mestranol Norethindrone Norethindrone acetate Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Norinyl Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Contraceptives, Oral, Combined Contraceptives, Oral, Hormonal Contraceptives, Oral, Sequential |
ClinicalTrials.gov processed this record on June 23, 2017