Trial Outcomes & Findings for Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070) (NCT NCT00945035)
NCT ID: NCT00945035
Last Updated: 2022-02-09
Results Overview
The area under the plasma concentration vs time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Through 120 Hours Postdose
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Etoricoxib FMI Then Etoricoxib URC
FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction
|
Etoricoxib URC Then Etoricoxib FMI
URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image
|
|---|---|---|
|
Period 1
STARTED
|
18
|
18
|
|
Period 1
COMPLETED
|
18
|
18
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
18
|
18
|
|
Period 2
COMPLETED
|
18
|
18
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
Baseline characteristics by cohort
| Measure |
All Participants in Study
n=36 Participants
|
|---|---|
|
Age, Continuous
|
36.1 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Height
|
168.3 Centimeters
n=5 Participants
|
|
Weight
|
75.2 Kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 120 Hours PostdosePopulation: All healthy adult subjects completed the study and were included in the statistical analysis.
The area under the plasma concentration vs time curve.
Outcome measures
| Measure |
Etoricoxib FMI
n=36 Participants
FMI Formulation (20%), Final Market Image.
|
Etoricoxib URC
n=36 Participants
URC Formulation (30%), Unmilled Roller Compaction
|
|---|---|---|
|
Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib
|
32.65 µg times hr/mL
Standard Deviation 16.20
|
33.28 µg times hr/mL
Standard Deviation 13.65
|
PRIMARY outcome
Timeframe: Through 120 Hours PostdosePopulation: All healthy adult subjects completed the study and were included in the statistical analysis.
Outcome measures
| Measure |
Etoricoxib FMI
n=36 Participants
FMI Formulation (20%), Final Market Image.
|
Etoricoxib URC
n=36 Participants
URC Formulation (30%), Unmilled Roller Compaction
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) for Etoricoxib
|
1964 ng/mL
Standard Deviation 701
|
2021 ng/mL
Standard Deviation 833
|
Adverse Events
Etoricoxib FMI
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Etoricoxib URC
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Etoricoxib FMI
n=36 participants at risk
FMI Formulation (20%), Final Market Image
|
Etoricoxib URC
n=36 participants at risk
URC Formulation (30%), Unmilled Roller Compaction
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
2.8%
1/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
5.6%
2/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Gastrointestinal disorders
Loose Stools
|
2.8%
1/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
0.00%
0/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
2.8%
1/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
2.8%
1/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
6/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
19.4%
7/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Nervous system disorders
Headache
|
2.8%
1/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
8.3%
3/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Nervous system disorders
Somnolence
|
8.3%
3/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
11.1%
4/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
2.8%
1/36
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER