Bioequivalence Study for Mejoral 500 Product

Study Overview
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Brief Summary
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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.

Official Title
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Single Blinded, Two-period, Two-treatment, Crossover, Randomized, Single Dose Bioequivalence Study of Two Oral Formulations With 500 mg of Paracetamol (Mejoral® 500 Tablets, Glaxosmithkline méxico s.a. De c.v. Vs. Tylenol® Caplets, Janssen Cilag de méxico, s. De r.l. De c.v.) in Healthy Subjects Under Fasting Conditions

Conditions
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Pain

Intervention / Treatment
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* Drug: Mejoral® 500 Tablets
* Drug: Tylenol® Caplets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent Men and women between 18 to 55 years of age, with good state of health Participants' body mass index must be between 18.0 and 27.0 Blood pressure (seated) up to 139 milliliters of mercury (mm/Hg) systolic and up to 89 mm/Hg diastolic, heart rate between 60 and 100 beats per minute and respiratory frequency between 14 and 20 breaths per minute The laboratory tests: Complete blood count with differential count, Chemical blood of 27 elements, Urinalysis, Non-Reactive Anti-hepatitis B virus (HBV) hepatitis B and Anti-hepatitis C antibodies (HCV) hepatitis C, Non-Reactive Human immunodeficiency virus (HIV) test, Negative Venereal Disease Research Laboratory (VDRL) test with maximum 3 months validity and allowed variation of +/-10% of the normal range Electrocardiogram (ECG) with no more than three months validity and with no clinically significant findings Pregnancy test, drug abuse test and alcohol test with negative results at selection visit and approximately 12 h before drug product administration in both study periods Exclusion Criteria: Participants with some alteration in their vital signs; who fail to comply with the proposed inclusion criteria Participants with a history of suffering cardiovascular, renal, hepatic, muscle, metabolic, gastrointestinal, neurological problems, endocrine, hematopoietic or any type of anemia, asthma, mental illness or other organic abnormalities. Participants who have had a muscle injury within the 21 days prior to the study Clinically significant abnormalities in the ECG, dyspepsia, gastritis, esophagitis, gastric or duodenal ulcer; participants who require any drug product other than test product during the course of study Exposed to inductors or liver enzyme inhibitors or drugs capable of altering urinary pH or any potentially toxic drugs, vitamins, herbal remedies within the 30 days prior to the beginning of the study Participant hospitalized for any problem during the seven months prior to the study start; received investigational product within 90 days prior to the study Allergic to any drug product, food or substance, require special diet; positive drug abuse, alcohol, pregnancy test, breast feeding women Donated or lost 450 milliliter (mL) or more blood within the 60 days prior to the beginning of the study Participants who have not been recorded in the the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) page Ingested alcohol, carbonated beverage, products containing xanthines, charcoal grilled nourishment, grapefruit or orange or who have smoked 24 h prior to the beginning of both study periods Subordination relationship between participants and investigators, an employee of the sponsor or the study site or members of their immediate family

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tylenol® Caplets, then Mejoral® 500 Tablets<br>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. | Drug: Mejoral® 500 Tablets<br>* 500 mg tablet of paracetamol<br>Drug: Tylenol® Caplets<br>* 500 mg tablet of paracetamol<br>|
| Experimental: Mejoral® 500 Tablets, then Tylenol® Caplets<br>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. | Drug: Mejoral® 500 Tablets<br>* 500 mg tablet of paracetamol<br>Drug: Tylenol® Caplets<br>* 500 mg tablet of paracetamol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |