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Bioequivalence Study for Mejoral 500 Product

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ClinicalTrials.gov Identifier: NCT02504775
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : May 27, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Mejoral® 500 Tablets Drug: Tylenol® Caplets Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: 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
Study Start Date : August 1, 2015
Actual Primary Completion Date : August 1, 2015
Actual Study Completion Date : August 19, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tylenol® Caplets, then Mejoral® 500 Tablets
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
500 mg tablet of paracetamol

Drug: Tylenol® Caplets
500 mg tablet of paracetamol

Experimental: Mejoral® 500 Tablets, then Tylenol® Caplets
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
500 mg tablet of paracetamol

Drug: Tylenol® Caplets
500 mg tablet of paracetamol




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)] [ Time Frame: 2 days ]
    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. Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)] [ Time Frame: 2 days ]
    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.

  3. Maximum Plasma Concentration (Cmax) [ Time Frame: 2 days ]
    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.


Secondary Outcome Measures :
  1. Time to Reach Maximum Plasma Concentration (Tmax) [ Time Frame: 2 days ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504775


Locations
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Mexico
GSK Investigational Site
Mexico City, Mexico, 14610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02504775     History of Changes
Other Study ID Numbers: 204779
First Posted: July 22, 2015    Key Record Dates
Results First Posted: May 27, 2016
Last Update Posted: July 19, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics