Trial Outcomes & Findings for Bioequivalence Study for Mejoral 500 Product (NCT NCT02504775)
NCT ID: NCT02504775
Last Updated: 2018-07-19
Results Overview
AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period.
COMPLETED
NA
28 participants
2 days
2018-07-19
Participant Flow
Recruitment was done in one center in Mexico.
Fifty two participants were screened for this study, out of which 15 participants were considered screening failure, 9 were kept as backup and 28 participants were randomized and all 28 of them completed the study.
Participant milestones
| Measure |
Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)
Participants first received one tablet of Tylenol® Caplets \[500 milligram (mg) of paracetamol\], orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Mejoral® 500 tablets (500 mg of paracetamol), orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting.
|
Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)
Participants first received one tablet of Mejoral® Tablets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Tylenol® 500 Caplets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting.
|
|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
|
Period 1
COMPLETED
|
14
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
14
|
14
|
|
Washout
COMPLETED
|
14
|
14
|
|
Washout
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
Bioequivalence Study for Mejoral 500 Product
Baseline characteristics by cohort
| Measure |
Overall Participants
n=28 Participants
Total number of participants who were randomized and received treatment.
|
|---|---|
|
Age, Continuous
|
30.8 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis
AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period.
Outcome measures
| Measure |
Tylenol® Caplets (Reference)
n=27 Participants
Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
Mejoral® 500 Tablets (Test)
n=27 Participants
Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]
|
15.212 hours*microgram/millilitre (h*μg/mL)
Standard Deviation 4.141
|
14.698 hours*microgram/millilitre (h*μg/mL)
Standard Deviation 4.520
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis
AUC(0-inf) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.
Outcome measures
| Measure |
Tylenol® Caplets (Reference)
n=27 Participants
Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
Mejoral® 500 Tablets (Test)
n=27 Participants
Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
|---|---|---|
|
Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]
|
15.972 h*μg/mL
Standard Deviation 4.239
|
15.620 h*μg/mL
Standard Deviation 4.681
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis
Cmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.
Outcome measures
| Measure |
Tylenol® Caplets (Reference)
n=27 Participants
Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
Mejoral® 500 Tablets (Test)
n=27 Participants
Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
7.182 micogram per mililitre (μg/mL)
Standard Deviation 2.841
|
8.118 micogram per mililitre (μg/mL)
Standard Deviation 3.938
|
SECONDARY outcome
Timeframe: 2 daysPopulation: One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis
Tmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.
Outcome measures
| Measure |
Tylenol® Caplets (Reference)
n=27 Participants
Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
Mejoral® 500 Tablets (Test)
n=27 Participants
Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
0.719 Hours (h)
Standard Deviation 0.474
|
0.738 Hours (h)
Standard Deviation 0.501
|
Adverse Events
Tylenol® Caplets
Mejoral® 500 Tablets
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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