HealthyPhase 1NCT05428306

Pharmacokinetic Interaction Between Ibuprofen and Acetaminophen, Tablets Administered Individually or in Combination

A Phase 1 study testing A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.), A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.) and A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.) in people with Healthy, run by Laboratorios Silanes S.A. de C.V. 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 study was carried out in the Clinical and Analytical Unit of the Pharmacology and Toxicology Department of the Faculty of Medicine of the Autonomous University of Nuevo León, with the aim of comparing the bioavailability (Cmax, AUC) of an oral formulation containing ibuprofen 400 mg/ Acetaminophen 1000 mg in… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.), A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.) and A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteMexico
Study dates: 23 Oct 2018to 1 Feb 2019
Phase: Phase 1
Are there results?: None posted in the registry

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

The subjects must have been accepted by the COFEPRIS research subjects registration database.
Subjects without a subordinate relationship with the researchers.
Subjects who have given informed consent in writing.
Subjects of both genders, aged between 18 and 55 years, Mexicans.
Subjects with no background of hypersensitivity or allergies to the drug under study or related drugs.
Body mass index between 18 and 27 kg/m2.

Show all 11Show fewer

Healthy subjects, according to the results of the complete clinical history, electrocardiogram and the integration of the results of the clinical analyses, carried out in certified clinical laboratories, without alterations that require a medical intervention as a consequence.
Subjects with negative results for immunological tests (Anti-HIV, Anti-hepatitis B and C, VDRL).
Subjects with negative results in drug abuse screening tests: tetrahydrocannabinoids, cocaine and amphetamines.
Negative (qualitative) pregnancy test for women of childbearing potential without Bilateral tubal obstruction or hysterectomy.
In the case of women of childbearing age, they must have a birth control method, including barrier methods, non-hormonal intrauterine device, or bilateral tubal obstruction.

Who cannot join

Subjects with recent history or physical examination evidence of gastrointestinal, renal, hepatic, endocrine, respiratory, cardiovascular, dermatological, or hematological disease that could affect the pharmacokinetic study of the product in research.
Subjects who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken drugs potentially toxic within 30 days before the start of the study.
Subjects who have received any medication during the 7 days before the start of the study.
Subjects who have been hospitalized for any problem during the three months before the start of the study.
Subjects who have been rejected by the registry database of research subjects of COFEPRIS, for having participated in a clinical study within the three months prior to the start of the study.
Subjects who have received investigational drugs within the previous 60 days th the start of the study.

Show all 11Show fewer

Subjects allergic to the study drug or related drugs.
Subjects who have ingested alcohol or drinks containing xanthines (coffee, tea, cocoa, chocolate, cola) or who have eaten charcoal-grilled food or grapefruit juice , at least 10 hours before the start of the study or who have smoked tobacco 24 hours before to the start of the internment period.
Subjects who have donated or lost 450 mL or more of blood within the previous 60 days of the beginning of the study.
Subjects with a history of drug and/or alcohol abuse according to the DSM-IV-TR Criteria.
Research subjects who presents alterations in the vital signs recorded during the selection.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000

Other trials in Mexico

About this study

Official title: Pharmacokinetic Interaction Study Between Ibuprofen 200 mg and Acetaminophen 500 mg, Tablets Administered Individually or in Combination, Single Dose in Healthy Subjects, Both Genders Under Fasting Conditions

Read the detailed description

The study design was crossover, 3 x 6 x 3, open, prospective and longitudinal, at a single dose of the combination of Ibuprofen 200mg/ Acetaminophen 500mg (2 tablets), administered orally versus each component administered individually Ibuprofen 400mg (1 tablet) or Acetaminophen 500 mg (2 tablets), with three treatments, three periods, six sequences with an elimination period (washout) of 1 week and with a number of 42 healthy subjects, of both genders, under fasting conditions. In order to compare the pharmacokinetic profile (Cmax and AUC 0-t) of the combination Ibuporfen/Acetaminophen 200 mg / 500 mg, single dose versus each component administered individually, to establish the non-interaction of the drugs in combination. Like, Characterize the pharmacokinetic parameters, Cmax and AUC 0-t, AUC 0-, Tmax, Ke and T1/2, of Ibuprofen and Acetaminophen after oral administration in a single dose. The frequency and type of adverse events with the two formulations were established.

Conditions: Healthy
Being tested: A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.), A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.), A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)
Keywords: Pharmacokinetic, No interaction, Fixed-dose combination (FDC), Ibuprofen, Acetaminophen, Pain
Medical subject headings: Pain

What participants receive

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

A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.)Drug
Also called IBU / ACETA
Formula : 200 mg/ 500 mg Pharmaceutical Form: Tablet Dosage: 400 mg / 1000 mg (2 tablets) Administration way: oral
A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.)Drug
Also called IBU
A2: Pharmaceutical Form: tablet Dosage: 400 mg (1 tablet) Administration way: oral
A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)Drug
Also called ACETA
A3:Pharmaceutical Form: tablet Formula: Acetaminophen 500 mg Dosage: 1000 mg (2 tablets) Administration way: oral

Study groups in NCT05428306
Study group	Role	What they receive
Group A: Ibuprofen/ Acetaminophen in fixed dose	Experimental	Pharmaceutical Form: Tablet Formula: Ibuprofen 200 mg/ Acetaminophen 500 mg Dosage: 400 mg / 1000 mg (2 tablets) Administration way: oral Receives: Drug: A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.)
Group B: Ibuprofen	Active comparator	Pharmaceutical Form: tablets Dosage: 400 mg (1 tablet) Administration way: oral Receives: Drug: A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.)
Group C: Acetaminophen	Active comparator	Pharmaceutical Form: Tablet Formula: Acetaminophen 500 mg Dosage: 1000 mg (2 tablets) Administration way: oral Receives: Drug: A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)

What is being measured

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

Maximum observed concentration following the treatment (Cmax),
Evaluate the pharmacokinetics profile of the fixed dose Ibuprofen/Acetaminophen, employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.
Measured: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
The area under the curve from time zero to the last measurable concentration (AUC 0-t)
Evaluate the fixed dose pharmacokinetics profile of Ibuprofen/Acetaminophen, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.
Measured: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours

Secondary outcomes (6)

The area under the curve from time zero to infinity calculated (AUC 0-inf)
Evaluate the fixed dose pharmacokinetics profile of Ibuprofen/Acetaminophen, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).
Measured: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Time of the maximum measured concentration (Tmax)
Evaluate the fixed dose pharmacokinetics profile of Ibuprofen/Acetaminophen employing time of the maximum measured concentration Tmax), Obtained graphically, from the plasma concentration profile with respect to time.
Measured: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Elimination rate (Ke)
Evaluate the fixed dose pharmacokinetics profile of Ibuprofen/Acetaminophen, employing the elimination rate (Ke), estimated from the terminal linear portion of the plasma concentration profile with respect to time (on a semi-log scale)
Measured: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Half time elimination (t1/2)
Evaluate the pharmacokinetics profile of the fixed dose Ibuprofen/Acetaminophen, employing the half time elimination (t1/2) by the quotient of Ln(2)Ke.
Measured: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Frequency of occurrence of adverse events
The percentage of frequency of appearance of each adverse event was evaluated.
Measured: 1, 8 and 16 days
Adverse Events
Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.
Measured: 1, 8 and 16 days

Timeline

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

23 Oct 20181 Feb 2019

First posted23 Jun 2022
Study start23 Oct 2018
Primary completion6 Nov 2018
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05428306
Sponsor's protocol ID: BD IP-Sil No.103-18
Status last verified: Jun 2022
First submitted: 15 Jun 2022
Last updated: 28 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Anderson BJ. Paracetamol (Acetaminophen): mechanisms of action. Paediatr Anaesth. 2008 Oct;18(10):915-21. doi: 10.1111/j.1460-9592.2008.02764.x.
PubMed 18811827
Bramlage P, Goldis A. Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers. BMC Pharmacol. 2008 Oct 29;8:18. doi: 10.1186/1471-2210-8-18.
PubMed 18959779
Tanner T, Aspley S, Munn A, Thomas T. The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol. BMC Clin Pharmacol. 2010 Jul 5;10:10. doi: 10.1186/1472-6904-10-10.
PubMed 20602760
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
PubMed 3450848

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Interaction Study Between Ibuprofen 200 mg and Acetaminophen 500 mg, Tablets Administered Individually or in Combination, Single Dose in Healthy Subjects, Both Genders Under Fasting Conditions
ClinicalTrials.gov ID: NCT05428306
Acronym / sponsor ID: BD IP-Sil No.103-18
Conditions: Healthy
Keywords: Pharmacokinetic, No interaction, Fixed-dose combination (FDC), Ibuprofen, Acetaminophen, Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 23 Oct 2018 (actual)
Primary completion: 6 Nov 2018 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 23 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A: Ibuprofen/ Acetaminophen in fixed dose	Experimental	Drug: A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.)Pharmaceutical Form: Tablet Formula: Ibuprofen 200 mg/ Acetaminophen 500 mg Dosage: 400 mg / 1000 mg (2 tablets) Administration way: oral
Group B: Ibuprofen	Active comparator	Drug: A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.)Pharmaceutical Form: tablets Dosage: 400 mg (1 tablet) Administration way: oral
Group C: Acetaminophen	Active comparator	Drug: A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)Pharmaceutical Form: Tablet Formula: Acetaminophen 500 mg Dosage: 1000 mg (2 tablets) Administration way: oral

Who may qualify

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

Key inclusion criteria (11 listed)

The subjects must have been accepted by the COFEPRIS research subjects registration database.
Subjects without a subordinate relationship with the researchers.
Subjects who have given informed consent in writing.
Subjects of both genders, aged between 18 and 55 years, Mexicans.
Subjects with no background of hypersensitivity or allergies to the drug under study or related drugs.

Key exclusion criteria (11 listed)

Subjects with recent history or physical examination evidence of gastrointestinal, renal, hepatic, endocrine, respiratory, cardiovascular, dermatological, or hematological disease that could affect the pharmacokinetic study of the product in research.
Subjects who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken drugs potentially toxic within 30 days before the start of the study.
Subjects who have received any medication during the 7 days before the start of the study.
Subjects who have been hospitalized for any problem during the three months before the start of the study.
Subjects who have been rejected by the registry database of research subjects of COFEPRIS, for having participated in a clinical study within the three months prior to the start of 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
A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.)Also: IBU / ACETAFormula : 200 mg/ 500 mg Pharmaceutical Form: Tablet Dosage: 400 mg / 1000 mg (2 tablets) Administration way: oral	Drug	Group A: Ibuprofen/ Acetaminophen in fixed dose
A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.)Also: IBUA2: Pharmaceutical Form: tablet Dosage: 400 mg (1 tablet) Administration way: oral	Drug	Group B: Ibuprofen
A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)Also: ACETAA3:Pharmaceutical Form: tablet Formula: Acetaminophen 500 mg Dosage: 1000 mg (2 tablets) Administration way: oral	Drug	Group C: Acetaminophen

Primary outcome

Maximum observed concentration following the treatment (Cmax),
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Evaluate the pharmacokinetics profile of the fixed dose Ibuprofen/Acetaminophen, employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.
The area under the curve from time zero to the last measurable concentration (AUC 0-t)
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Evaluate the fixed dose pharmacokinetics profile of Ibuprofen/Acetaminophen, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.

6 secondary outcomes

The area under the curve from time zero to infinity calculated (AUC 0-inf)
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Time of the maximum measured concentration (Tmax)
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Elimination rate (Ke)
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Half time elimination (t1/2)
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours
Frequency of occurrence of adverse events
Time frame: 1, 8 and 16 days
Adverse Events
Time frame: 1, 8 and 16 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
Background: PubMed 18811827Anderson BJ. Paracetamol (Acetaminophen): mechanisms of action. Paediatr Anaesth. 2008 Oct;18(10):915-21. doi: 10.1111/j.1460-9592.2008.02764.x.
Background: PubMed 18959779Bramlage P, Goldis A. Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers. BMC Pharmacol. 2008 Oct 29;8:18. doi: 10.1186/1471-2210-8-18.
Background: PubMed 20602760Tanner T, Aspley S, Munn A, Thomas T. The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol. BMC Clin Pharmacol. 2010 Jul 5;10:10. doi: 10.1186/1472-6904-10-10.
Background: PubMed 3450848Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
Individual participant dataSharing planned: No

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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.

Lourdes Garza Ocaña, M.D principal investigator

Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

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

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 11 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 28 Jun 2022. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum observed concentration following the treatment (Cmax), (time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours). The study lists 2 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 NCT05428306, which also lists 4 linked publications.

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 28 Jun 2022.