Trial Outcomes & Findings for A Study to Compare the Amount of Meloxicam in the Blood When it is Taken as Capsules or as Tablets (NCT NCT03684265)
NCT ID: NCT03684265
Last Updated: 2019-11-22
Results Overview
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t). Standard error is actually Geometric standard error.
COMPLETED
PHASE1
26 participants
Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
2019-11-22
Participant Flow
The trial was a randomised, two-period, two sequences, single-dose, open-label, and crossover trial in healthy male and female subjects in fasting conditions.
All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated. In this study, 26 subjects were entered \& treated.
Participant milestones
| Measure |
Movalis® Capsules (T), Then Movalis® Tablets (R)
Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 hours (h) in Period 1, followed with single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 2.
The washout period between two drug administrations was of 7 days.
|
Movalis® Tablets (R), Then Movalis® Capsules (T)
Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 1, followed with single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h in Period 2.
The washout period between two drug administrations was of 7 days.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
13
|
13
|
|
Treatment Period 1
COMPLETED
|
13
|
13
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 1 Week
STARTED
|
13
|
13
|
|
Washout Period of 1 Week
COMPLETED
|
13
|
13
|
|
Washout Period of 1 Week
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
13
|
13
|
|
Treatment Period 2
COMPLETED
|
13
|
13
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Amount of Meloxicam in the Blood When it is Taken as Capsules or as Tablets
Baseline characteristics by cohort
| Measure |
Movalis® Capsules (T), Then Movalis® Tablets (R)
n=13 Participants
Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 hours (h) in Period 1, followed with single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 2.
The washout period between two drug administrations was of 7 days.
|
Movalis® Tablets (R), Then Movalis® Capsules (T)
n=13 Participants
Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 1, followed with single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h in Period 2.
The washout period between two drug administrations was of 7 days.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
29.5 Years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
30.0 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Paticipants
n=5 Participants
|
13 Paticipants
n=7 Participants
|
26 Paticipants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dosePopulation: Pharmacokinetic set (PKS): This set includes all randomised subjects who met the protocol requirements without important protocol deviation and completed all study periods.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t). Standard error is actually Geometric standard error.
Outcome measures
| Measure |
Movalis® Capsules (T)
n=26 Participants
Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h.
|
Movalis® Tablets (R)
n=26 Participants
Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-t)
|
27870.56 Nanogram (ng)·hour (h)/ mililiter(mL)
Standard Error 1.06
|
30051.25 Nanogram (ng)·hour (h)/ mililiter(mL)
Standard Error 1.06
|
PRIMARY outcome
Timeframe: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dosePopulation: PKS
Maximum measured concentration of the analyte in plasma (Cmax). Standard error is actually Geometric standard error.
Outcome measures
| Measure |
Movalis® Capsules (T)
n=26 Participants
Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h.
|
Movalis® Tablets (R)
n=26 Participants
Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h.
|
|---|---|---|
|
Maximum Measured Concentration of the Analyte in Plasma (Cmax)
|
1131.12 ng/mL
Standard Error 1.04
|
1432.83 ng/mL
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dosePopulation: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Standard error is actually Geometric standard error.
Outcome measures
| Measure |
Movalis® Capsules (T)
n=26 Participants
Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h.
|
Movalis® Tablets (R)
n=26 Participants
Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
32863.87 ng·h/mL
Standard Error 1.09
|
33867.43 ng·h/mL
Standard Error 1.09
|
Adverse Events
Movalis® Capsules (T)
Movalis® Tablets (R)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER