PainNCT02504775

Bioequivalence Study for Mejoral 500 Product

A study testing Mejoral® 500 Tablets and Tylenol® Caplets in people with Pain, run by GlaxoSmithKline at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Mejoral® 500 Tablets and Tylenol® Caplets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteMexico
Study dates: 1 Aug 2015to 19 Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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 locations and contacts

1 site in 1 country.

Mexico1 site

GSK Investigational Site
Mexico City, 14610

Other trials in Mexico

About this study

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

Conditions: Pain
Being tested: Mejoral® 500 Tablets, Tylenol® Caplets
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mejoral® 500 TabletsDrug
500 mg tablet of paracetamol
Tylenol® CapletsDrug
500 mg tablet of paracetamol

Study groups in NCT02504775
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Mejoral® 500 Tablets; Drug: Tylenol® Caplets

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 2 days

Secondary outcomes (1)

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.
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201519 Aug 2015

First posted22 Jul 2015 (estimated)
Study start1 Aug 2015
Primary completion1 Aug 2015
Study completion19 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02504775
Sponsor's protocol ID: 204779
Status last verified: May 2018
First submitted: 20 Jul 2015
Last updated: 19 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02504775
Acronym / sponsor ID: 204779
Conditions: Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Aug 2015
Primary completion: 1 Aug 2015 (actual)
Study completion: 19 Aug 2015 (actual)
First posted: 22 Jul 2015 (estimated)
Results: Posted 27 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Tylenol® Caplets, then Mejoral® 500 Tablets	Experimental	Drug: Mejoral® 500 Tablets, Drug: Tylenol® CapletsParticipants 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.
Mejoral® 500 Tablets, then Tylenol® Caplets	Experimental	Drug: Mejoral® 500 Tablets, Drug: Tylenol® CapletsParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mejoral® 500 Tablets500 mg tablet of paracetamol	Drug	Mejoral® 500 Tablets, then Tylenol® Caplets, Tylenol® Caplets, then Mejoral® 500 Tablets
Tylenol® Caplets500 mg tablet of paracetamol	Drug	Mejoral® 500 Tablets, then Tylenol® Caplets, Tylenol® Caplets, then Mejoral® 500 Tablets

Primary outcome

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.
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.
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.

1 secondary outcome

Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 2 days

Results and safety

Results posted to the registry on 27 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)	14	14
Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)	14	14

Primary outcome: Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]

Time frame: 2 days. Mean (Standard Deviation). Unit: hours*microgram/millilitre (h*μg/mL)

Measure	Tylenol® Caplets (Reference) n = 27	Mejoral® 500 Tablets (Test) n = 27
Value	15.212 (4.141)	14.698 (4.520)

Tylenol® Caplets (Reference) vs Mejoral® 500 Tablets (Test): Ratio of Averages of Tylenol/Mejoral: 94.704 (90% CI 88.329 to 101.540), ANOVA

Population analysed: One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis

Primary outcome: Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]

Time frame: 2 days. Mean (Standard Deviation). Unit: h*μg/mL

Measure	Tylenol® Caplets n = 27	Mejoral® 500 Tablets n = 27
Value	15.972 (4.239)	15.620 (4.681)

Tylenol® Caplets vs Mejoral® 500 Tablets: Ratio of Averages of Tylenol/Mejoral: 95.989 (90% CI 89.826 to 102.574), ANOVA

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: 2 days. Mean (Standard Deviation). Unit: micogram per mililitre (μg/mL)

Measure	Tylenol® Caplets n = 27	Mejoral® 500 Tablets n = 27
Value	7.182 (2.841)	8.118 (3.938)

Tylenol® Caplets vs Mejoral® 500 Tablets: Ratio of Averages of Tylenol/Mejoral: 106.132 (90% CI 85.151 to 132.283), ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: upto 14 days after administration of investigational product. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tylenol® Caplets	0 of 28 (0%)	0 of 28 (0%)	Not reported
Mejoral® 500 Tablets	0 of 28 (0%)	0 of 28 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mejoral® 500 Tablets and Tylenol® Caplets in people with Pain, run by GlaxoSmithKline at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)] (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02504775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.