Pain
Conditions
Brief summary
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.
Interventions
DRUGetoricoxib
Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is in good health * Subject agrees to follow the study guidelines
Exclusion criteria
* Subject is a smoker * Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs * Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib | Through 120 Hours Postdose | The area under the plasma concentration vs time curve. |
| Peak Plasma Concentration (Cmax) for Etoricoxib | Through 120 Hours Postdose | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants in Study | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | All Participants in Study |
|---|---|
| Age, Continuous | 36.1 Years |
| Height | 168.3 Centimeters |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 19 Participants |
| Weight | 75.2 Kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 36 | 12 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Peak Plasma Concentration (Cmax) for Etoricoxib
Time frame: Through 120 Hours Postdose
Population: All healthy adult subjects completed the study and were included in the statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib FMI | Peak Plasma Concentration (Cmax) for Etoricoxib | 1964 ng/mL | Standard Deviation 701 |
| Etoricoxib URC | Peak Plasma Concentration (Cmax) for Etoricoxib | 2021 ng/mL | Standard Deviation 833 |
Comparison: Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction90% CI: [0.95, 1.11]
Primary
Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib
The area under the plasma concentration vs time curve.
Time frame: Through 120 Hours Postdose
Population: All healthy adult subjects completed the study and were included in the statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib FMI | Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib | 32.65 µg times hr/mL | Standard Deviation 16.2 |
| Etoricoxib URC | Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib | 33.28 µg times hr/mL | Standard Deviation 13.65 |
Comparison: Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction90% CI: [0.97, 1.07]