Trial Outcomes & Findings for Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution) (NCT NCT05716763)
NCT ID: NCT05716763
Last Updated: 2024-12-16
Results Overview
The maximum concentration in plasma among observed concentrations at pre-specified time points
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours
Results posted on
2024-12-16
Participant Flow
cross-over study.
Participant milestones
| Measure |
Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0 Then Tramadol HCl 100mg/mL Oral Solution Contramal(r)
Participants first received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state. After a washout period of 1 week, they received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state
|
Tramadol HCl 100mg/mL Oral Solution Contramal(r) Then Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0
Participants first received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state. After a washout period of 1 week, they received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state.
|
|---|---|---|
|
Period I
STARTED
|
12
|
12
|
|
Period I
COMPLETED
|
12
|
12
|
|
Period I
NOT COMPLETED
|
0
|
0
|
|
Period II
STARTED
|
12
|
12
|
|
Period II
COMPLETED
|
12
|
12
|
|
Period II
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0 Then Tramadol HCl 100mg/mL Oral Solution Contramal(r)
n=12 Participants
Participants first received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state. After a washout period of 1 week, they received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state
|
Tramadol HCl 100mg/mL Oral Solution Contramal(r) Then Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0
n=12 Participants
Participants first received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state. After a washout period of 1 week, they received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 6.6 • n=12 Participants
|
29 years
STANDARD_DEVIATION 7.3 • n=12 Participants
|
27 years
STANDARD_DEVIATION 7.08 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
24 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Jordan
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
24 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hoursThe maximum concentration in plasma among observed concentrations at pre-specified time points
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
Cmax of Tramadol Hydrochloride for the Test and the Reference Products
|
139.65 ng/mL
Standard Deviation 53.01
|
123.90 ng/mL
Standard Deviation 36.02
|
PRIMARY outcome
Timeframe: predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hoursThe area under the plasma concentration versus time curve from time 0 to the last measured concentration
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products
|
902.01 ng*h/mL
Standard Deviation 339.22
|
812.63 ng*h/mL
Standard Deviation 301.24
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hoursThe area under the plasma concentration versus time curve from time 0 to to infinite time
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products
|
965.92 ng*h/mL
Standard Deviation 385.19
|
873.74 ng*h/mL
Standard Deviation 344.86
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hoursThe elimination rate constant
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
Kel of Tramadol Hydrochloride for the Test and the Reference Products
|
0.1344 L/h
Standard Deviation 0.04
|
0.1294 L/h
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hoursTime of the maximum measured plasma concentration. Determined directly from the plasma concentration-time curve. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
Tmax of Tramadol Hydrochloride for the Test and the Reference Products
|
1.5 h
Interval 0.5 to 2.5
|
1 h
Interval 0.5 to 2.5
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hoursPlasma Elimination Half-Life
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
T1/2 of Tramadol Hydrochloride for the Test and the Reference Products
|
5.48 h
Standard Deviation 1.33
|
5.71 h
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Day 1 to Day 11 (end of study)Occurence and severity of adverse events (serious and non serious adverse events)
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
Number of Treatment-related Adverse Events
|
0 adverse events
|
0 adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 and 2 minutes5 point scale: from 1 : very bad after taste to 5 : very good after taste
Outcome measures
| Measure |
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
n=24 Participants
Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose
|
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
n=24 Participants
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose
|
|---|---|---|
|
Palatability Questionnaire
no after taste at 2 min
|
4.17 percentage of participant
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20.83 percentage of participant
|
|
Palatability Questionnaire
good after taste at 2 min
|
66.67 percentage of participant
|
41.67 percentage of participant
|
|
Palatability Questionnaire
very good after taste at 2 min
|
25 percentage of participant
|
4.17 percentage of participant
|
|
Palatability Questionnaire
very bad taste at 0 min
|
4.17 percentage of participant
|
4.17 percentage of participant
|
|
Palatability Questionnaire
bad taste at 0 min
|
12.5 percentage of participant
|
33.33 percentage of participant
|
|
Palatability Questionnaire
no taste at 0 min
|
0 percentage of participant
|
0 percentage of participant
|
|
Palatability Questionnaire
good taste at 0 min
|
66.67 percentage of participant
|
54.17 percentage of participant
|
|
Palatability Questionnaire
very good taste at 0 min
|
16.67 percentage of participant
|
8.33 percentage of participant
|
|
Palatability Questionnaire
Very bad after taste at 2 min
|
0 percentage of participant
|
4.17 percentage of participant
|
|
Palatability Questionnaire
bad after taste at 2 min
|
4.17 percentage of participant
|
29.17 percentage of participant
|
Adverse Events
Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r))
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Non-clinical & clinical Project Manager
Unither-Pharmaceuticals
Phone: 33 (0)1 44 63 51 78
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study are Unither-Pharmaceuticals proprietary and cannot be published or presented in any scientific meeting without any agreement from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER