Trial Outcomes & Findings for Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers (NCT NCT01246791)
NCT ID: NCT01246791
Last Updated: 2025-06-17
Results Overview
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.
COMPLETED
PHASE3
12 participants
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
2025-06-17
Participant Flow
Thirty healthy female are screened for this study. Appropriate subjects who satisfy inclusion criteria were enrolled for this study.
Participant milestones
| Measure |
NPC-01
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Baseline characteristics by cohort
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
12 participants
n=5 Participants
|
|
Height
|
158.98 cm
STANDARD_DEVIATION 6.31 • n=5 Participants
|
|
Body weight
|
54.46 kg
STANDARD_DEVIATION 9.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01
|
69.183 ng･hr/mL
Standard Deviation 36.316
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01
|
368.123 pg･hr/mL
Standard Deviation 170.882
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01
|
12.481 ng/mL
Standard Deviation 6.205
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01
|
55.783 pg/mL
Standard Deviation 17.201
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01
|
1.81 hours
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01
|
1.50 hours
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Plasma Half Life (t1/2) on Norethisterone of NPC-01
|
7.357 hours
Standard Deviation 1.863
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01
|
5.499 hours
Standard Deviation 2.207
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Mean Residence Time (MRT) on Norethisterone of NPC-01
|
6.340 hours
Standard Deviation 0.459
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01
|
5.161 hours
Standard Deviation 1.504
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Elimination Rate Constant (Kel) on Norethisterone of NPC-01
|
0.101 hr^-1
Standard Deviation 0.029
|
PRIMARY outcome
Timeframe: 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-01Multiple 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.
Outcome measures
| Measure |
NPC-01
n=12 Participants
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01
|
0.141 hr^-1
Standard Deviation 0.043
|
Adverse Events
NPC-01
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPC-01
n=12 participants at risk
Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
|
|---|---|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From initiation of study drug administration to follow up visit (day 7±1 day)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
16.7%
2/12 • Number of events 2 • From initiation of study drug administration to follow up visit (day 7±1 day)
|
|
Investigations
Blood iron decreased
|
8.3%
1/12 • Number of events 1 • From initiation of study drug administration to follow up visit (day 7±1 day)
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12 • Number of events 1 • From initiation of study drug administration to follow up visit (day 7±1 day)
|
Additional Information
Department director of clinical development department 1
Nobelpharma
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the sponsor and PI that no restricts the PI's right but need to discuss the timing of publish date of trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER