Trial Outcomes & Findings for Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride (NCT NCT02943213)
NCT ID: NCT02943213
Last Updated: 2017-11-14
Results Overview
Time Frame = sampling times.
COMPLETED
PHASE1
20 participants
0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
2017-11-14
Participant Flow
Study volunteers each received a single dose of 25 mg Chlorpromazine Hydrochloride Tablet in both treatment periods.
Participant milestones
| Measure |
Chlorpromazine 25 mg
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
|---|---|
|
Treatment Period 1
STARTED
|
20
|
|
Treatment Period 1
COMPLETED
|
20
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
|
Treatment Period 2
STARTED
|
20
|
|
Treatment Period 2
COMPLETED
|
20
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Baseline characteristics by cohort
| Measure |
Chlorpromazine 25 mg
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times.
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine
|
2671 pg/mL
Geometric Coefficient of Variation 94.5
|
2720 pg/mL
Geometric Coefficient of Variation 69.6
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times.
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine
|
1539 pg/mL
Geometric Coefficient of Variation 57.6
|
1583 pg/mL
Geometric Coefficient of Variation 48.9
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times.
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine
|
18670 h*pg/mL
Geometric Coefficient of Variation 91.9
|
18470 h*pg/mL
Geometric Coefficient of Variation 98.0
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times.
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine
|
13280 h*pg/mL
Geometric Coefficient of Variation 58.4
|
13190 h*pg/mL
Geometric Coefficient of Variation 61.6
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times.
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine
|
15790 h*pg/mL
Geometric Coefficient of Variation 74.9
|
19650 h*pg/mL
Geometric Coefficient of Variation 106.2
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times.
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine
|
14460 h*pg/mL
Geometric Coefficient of Variation 55.2
|
13740 h*pg/mL
Geometric Coefficient of Variation 60.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine
|
1.33 hr
Interval 1.0 to 2.0
|
1.33 hr
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine
|
2.00 hr
Interval 1.33 to 3.0
|
1.83 hr
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz) - Chlorpromazine
|
0.05060 1/hr
Geometric Coefficient of Variation 17.9
|
0.04117 1/hr
Geometric Coefficient of Variation 32.6
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine
|
0.07153 1/hr
Geometric Coefficient of Variation 19.5
|
0.07025 1/hr
Geometric Coefficient of Variation 19.8
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine
|
13.70 hr
Geometric Coefficient of Variation 17.7
|
16.84 hr
Geometric Coefficient of Variation 40.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hoursPopulation: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.
Time Frame = sampling times
Outcome measures
| Measure |
Treatment Period 1
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 Participants
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine
|
9.690 hr
Geometric Coefficient of Variation 31.8
|
9.867 hr
Geometric Coefficient of Variation 28.1
|
Adverse Events
Treatment Period 1
Treatment Period 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Period 1
n=20 participants at risk
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
|
Treatment Period 2
n=20 participants at risk
All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia Left Index Finger
|
5.0%
1/20 • From first visit first dose until post-study visit.
|
0.00%
0/20 • From first visit first dose until post-study visit.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • From first visit first dose until post-study visit.
|
5.0%
1/20 • From first visit first dose until post-study visit.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury Right Side of Body
|
5.0%
1/20 • From first visit first dose until post-study visit.
|
0.00%
0/20 • From first visit first dose until post-study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place