Last updated: 11/03/2018 22:49:35
Bioequivalence study for Mejoral 500 product
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Area under the curve from time zero to last sampling time [AUC(0-t)]
Timeframe: 2 days
Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]
Timeframe: 2 days
Maximum plasma concentration (Cmax)
Timeframe: 2 days
Secondary outcomes:
Time to reach maximum plasma concentration (Tmax)
Timeframe: 2 days
Interventions:
Drug: Mejoral® 500 Tablets
Drug: Tylenol® Caplets
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2015-19-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain
Product
paracetamol
Collaborators
Not applicable
Study date(s)
August 2015 to August 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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 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
Inclusion and exclusion 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
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-19-08
Actual study completion date
2015-19-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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