Bioequivalence Study for Mejoral 500 Product

NCT02504775 | Completed Results

• 1 other identifier: 204779
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Time to Reach Maximum Plasma Concentration (Tmax)

  2 days

Study Arms (2)

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.

Drug: Mejoral® 500 Tablets; Drug: Tylenol® Caplets

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.

Drug: Mejoral® 500 Tablets; Drug: Tylenol® Caplets

Interventions

Mejoral® 500 Tablets DRUG

500 mg tablet of paracetamol

Mejoral® 500 Tablets, then Tylenol® Caplets; Tylenol® Caplets, then Mejoral® 500 Tablets

Tylenol® Caplets DRUG

500 mg tablet of paracetamol

Mejoral® 500 Tablets, then Tylenol® Caplets; Tylenol® Caplets, then Mejoral® 500 Tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mexico City, 14610, Mexico

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 19, 2015
• Last Updated: July 19, 2018
• Results First Posted: May 27, 2016

Record last verified: 2018-05

Locations

ME (1)