Overview

Bioequivalence Study for Mejoral 500 Product

Status:
Completed
Trial end date:
2015-08-19
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Acetaminophen
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