Trial Outcomes & Findings for This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. (NCT NCT01750931)
NCT ID: NCT01750931
Last Updated: 2017-07-17
Results Overview
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants
COMPLETED
NA
28 participants
Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
2017-07-17
Participant Flow
Total 28 participants were enrolled from September-2013 to October-2013. At each study period participants received test (GlaxoSmithKline \[GSK\]-meloxicam 15 milligram \[mg\] tablet) and reference (Mobic®-meloxicam 15 mg tablet) products. Mobic is registered product of Boehringer Ingelheim Pharma GmbH and Company, Germany.
Participant milestones
| Measure |
GSK-meloxicam Then Mobic-meloxicam
In this period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) followed by reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
|
Mobic-meloxicam Then GSK-meloxicam
In this period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) followed by test (GSK-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
|
|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
|
Period 1
COMPLETED
|
14
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Wash Out
STARTED
|
14
|
14
|
|
Wash Out
COMPLETED
|
14
|
14
|
|
Wash Out
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
14
|
14
|
|
Period 2
COMPLETED
|
14
|
14
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
Baseline characteristics by cohort
| Measure |
GSK-meloxicam 15 mg + Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) or reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
|
|---|---|
|
Age, Continuous
Years
|
25.04 Years
STANDARD_DEVIATION 4.14 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
|
Region of Enrollment
India
|
28 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment periodPopulation: All subject population: all participants who complete all periods of the study. All participants were present at the time of measurement.
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose
|
1889.579 Nanogram per milliliter
Geometric Coefficient of Variation 15.31
|
1844.423 Nanogram per milliliter
Geometric Coefficient of Variation 15.74
|
PRIMARY outcome
Timeframe: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment periodPopulation: All subject population
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The Tmax was taken directly from the plasma concentration-time profile of individual participants. Plasma samples for PK analysis were drawn at indicated time points.
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
Time to Maximum Concentration (T-max)
|
5.50 Hour
Full Range 16.0 • Interval 5.0 to 8.02
|
5.50 Hour
Full Range 14.7 • Interval 5.0 to 8.0
|
PRIMARY outcome
Timeframe: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment periodPopulation: All subject population. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC(0-t) was area under the plasma concentration-time curve from time of administration until the time of last quantifiable concentration. The area under the plasma concentration-time curve (AUC0-infinity), was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose
AUC(0-t)
|
57499.339 Nanogram.hour per milliliter
Geometric Coefficient of Variation 31.00
|
54750.590 Nanogram.hour per milliliter
Geometric Coefficient of Variation 33.21
|
|
The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose
AUC(0-inf)
|
62687.372 Nanogram.hour per milliliter
Geometric Coefficient of Variation 44.49
|
61269.334 Nanogram.hour per milliliter
Geometric Coefficient of Variation 50.30
|
PRIMARY outcome
Timeframe: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment periodPopulation: All subject population. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The percentage of area under curve extrapolated to arrive at AUC0-infinity (AUC%\_Extrap \[residual area\]) was determined by AUC0-infinity minus AUC0-t divided by AUC0-infinity multiplied by 100.
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
The Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUCpercentage [%]_Extrap [Residual Area]) After a Single Dose
|
4.32 Percentage of AUC Extrapolated
Geometric Coefficient of Variation 119.8
|
5.02 Percentage of AUC Extrapolated
Geometric Coefficient of Variation 132.1
|
PRIMARY outcome
Timeframe: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment periodPopulation: All subject population. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semilogarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
Elimination Rate Constant (Kel) After a Single Dose
|
0.032 Per hour
Geometric Coefficient of Variation 33.91
|
0.030 Per hour
Geometric Coefficient of Variation 34.50
|
PRIMARY outcome
Timeframe: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment periodPopulation: All subject population. All participants were present at the time of measurement.
The T-half was calculated using the following formula by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
Elimination Half Life (T-half) After a Single Dose
|
21.362 Per hour
Interval 11.437 to 66.697
|
22.337 Per hour
Interval 12.522 to 92.217
|
SECONDARY outcome
Timeframe: Up to 20 daysPopulation: All subject population.
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, is medically important event or reaction, is associated with liver injury Alanine amino transferase (more than equal to \[\>=\] 3 fold upper normal of limit \[ULN\]) or total bilirubin (\>=2 fold ULN) or international normalization ratio more than 1.5. Refer to the general AE/SAE module for a list of AEs and SAEs.
Outcome measures
| Measure |
GSK-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 Participants
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
0 Participants
|
0 Participants
|
Adverse Events
GSK-meloxicam 15 mg
Mobic-meloxicam 15 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK-meloxicam 15 mg
n=28 participants at risk
In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
Mobic-meloxicam 15 mg
n=28 participants at risk
In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/28 • AE and SAE were reported through out the study (up to 20 days)
For reporting AE and SAE, all subject population was used.
|
3.6%
1/28 • AE and SAE were reported through out the study (up to 20 days)
For reporting AE and SAE, all subject population was used.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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