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This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tylenol® Caplets, then Mejoral® 500 Tablets | Experimental | Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. |
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| Mejoral® 500 Tablets, then Tylenol® Caplets | Experimental | Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mejoral® 500 Tablets | Drug | 500 mg tablet of paracetamol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)] | 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. | 2 days |
| Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)] | 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. | 2 days |
| Maximum Plasma Concentration (Cmax) | 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. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) | 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. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mexico City | 14610 | 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.
Recruitment was done in one center in Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Total number of participants who were randomized and received treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)] | 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. | 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 | Posted | Mean | Standard Deviation | hours*microgram/millilitre (h*μg/mL) | 2 days |
|
upto 14 days after administration of investigational product
MedDRA
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tylenol® Caplets | Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Tylenol® Caplets | Drug | 500 mg tablet of paracetamol |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Mejoral® 500 Tablets (Test) | 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 |
|
|
|
| Primary | Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)] | 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. | 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 | Posted | Mean | Standard Deviation | h*μg/mL | 2 days |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) | 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. | 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 | Posted | Mean | Standard Deviation | micogram per mililitre (μg/mL) | 2 days |
|
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) | 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. | 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 | Posted | Mean | Standard Deviation | Hours (h) | 2 days |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Mejoral® 500 Tablets | Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. | 0 | 28 | 0 | 28 |
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.