Trial Outcomes & Findings for Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers (NCT NCT05014490)
NCT ID: NCT05014490
Last Updated: 2024-11-29
Results Overview
The Cmax values are based on the etoricoxib plasma concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
Results posted on
2024-11-29
Participant Flow
Participant milestones
| Measure |
Exib (Test) First
Exib 120 mg etoricoxib film-coated tablets (test product) dosed in first period followed by Arcoxia 120 mg etoricoxib film-coated tablets (reference product) dosed in the second period.
|
Arcoxia® (Reference) First
Arcoxia 120 mg etoricoxib film-coated tablets (reference product) dosed in first period followed by Exib 120 mg etoricoxib film-coated tablets (test product) dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
14
|
|
First Intervention
COMPLETED
|
14
|
14
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
14
|
14
|
|
Second Intervention
COMPLETED
|
14
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Exib (Test) First
n=14 Participants
Exib 120 mg etoricoxib film-coated tablets (test product) dosed in first period followed by Arcoxia 120 mg etoricoxib film-coated tablets (reference product) dosed in the second period.
|
Arcoxia® (Reference) First
n=14 Participants
Arcoxia 120 mg etoricoxib film-coated tablets (reference product) dosed in first period followed by Exib 120 mg etoricoxib film-coated tablets (test product) dosed in the second period.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.Population: All participants that completed the study had their samples analyzed.
The Cmax values are based on the etoricoxib plasma concentration.
Outcome measures
| Measure |
Test (Exib)
n=28 Participants
120 mg Exib film-coated tablets test product dosed in either period.
|
Reference (Arcoxia®)
n=28 Participants
120 mg Arcoxia® film-coated tablets reference product dosed in either period.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
1948.656 ng/mL
Standard Deviation 577.431
|
1916.300 ng/mL
Standard Deviation 602.446
|
PRIMARY outcome
Timeframe: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.Population: All participants that completed the study had their samples analyzed.
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on the etoricoxib plasma concentration.
Outcome measures
| Measure |
Test (Exib)
n=28 Participants
120 mg Exib film-coated tablets test product dosed in either period.
|
Reference (Arcoxia®)
n=28 Participants
120 mg Arcoxia® film-coated tablets reference product dosed in either period.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
|
21967.848 h*ng/mL
Standard Deviation 5570.437
|
22205.479 h*ng/mL
Standard Deviation 6046.728
|
Adverse Events
Test (Exib)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Reference (Arcoxia®)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Exib)
n=28 participants at risk
120 mg Exib film-coated tablets test product dosed in either period.
|
Reference (Arcoxia®)
n=28 participants at risk
120 mg Arcoxia® film-coated tablets reference product dosed in either period.
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • Information on AEs was continuously collected throughout the study from the screening until the follow up visit up to 23 days for each subject.
Safety population included all dosed participants.
|
3.6%
1/28 • Number of events 1 • Information on AEs was continuously collected throughout the study from the screening until the follow up visit up to 23 days for each subject.
Safety population included all dosed participants.
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • Information on AEs was continuously collected throughout the study from the screening until the follow up visit up to 23 days for each subject.
Safety population included all dosed participants.
|
0.00%
0/28 • Information on AEs was continuously collected throughout the study from the screening until the follow up visit up to 23 days for each subject.
Safety population included all dosed participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.6%
1/28 • Number of events 1 • Information on AEs was continuously collected throughout the study from the screening until the follow up visit up to 23 days for each subject.
Safety population included all dosed participants.
|
3.6%
1/28 • Number of events 1 • Information on AEs was continuously collected throughout the study from the screening until the follow up visit up to 23 days for each subject.
Safety population included all dosed participants.
|
Additional Information
Andrii Doroshenko, PhD, MD
PrJSC "Pharmaceutical Firm "Darnytsia"
Phone: +38 044 207 73 53
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place