HealthyPhase 1NCT07444164

Comparative Bioavailability Study Between Ticagrelor and ASA Administered Individually or in Combination.

A Phase 1 study testing A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.) and A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.) and A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México 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: 24 participants
Where: 1 siteMexico
Study dates: 13 Jan 2025to 5 Feb 2025
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

Subjects who have given informed consent in writting
Subjects of both genders aged between 18 and 55 years, mexicans, with no background of hypersensitivity or allergies to the drugs under study or related drugs.
Subjects with no background of using anticoagulants of any kind.
Subjects with no background of hepatitis B and/or C.
Vital signs within normal limits, according to international guidelines recorded during selection.
Electrocardiographic trace without evidence of conduction disorders, with RR, PR, QRS, and QT ranges and ST segment values within physiological limits.

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Body mass index between 18.0 - 27.0 (kg/m2).
Negative drug abuse test for both men and women.
Negative pregnancy test for women.
All women who agree to participate in the study and who use some form of contraception barrier method such as male or female condoms, copper intrauterine devices (IUDs), or male or female sterilization.
No background of food allergies.
No background of medication use for 14 consecutive days or less than 9 half-lives of the last dose administered of the indicated medication prior to the start of the study.
Background of participation in clinical studies similar to this one within a period of 3 months prior to the study.
No presence of Hepatitis B surface antigens or antibodies against Hepatitis C, HIV, and VDRL core proteins.
No background of alcohol consumption during the study selection period.
No background of donating or losing 450 mL or more of blood within 60 days prior to the study.

Who cannot join

Individuals with hypersensitivity to ticagrelor, acetylsalicylic acid, or any of their components.
Subjects with background of use of anticoagulants.
Subjects with background of hepatitis B and/or C.
Vital signs outside normal limits, according to international guidelines recorded during selection.
Electrocardiogram showing evidence of conduction disturbances, with RR, PR, QRS, and QT intervals and ST segment values within physiological limits.
Body mass index below 18.0 (kg/m2) or above 27.0 (kg/m2).

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During the medical history process, the subject indicated background of abuse and dependence on alcohol, psychoactive substances, and chronic use of medications.
Positive drug abuse test for both men and women.
Positive pregnancy test for women.
Background of food allergies.
Background of participation in clinical studies similar to the present study within a period of less than 3 months prior to the study.
Presence of Hepatitis B surface antigens or antibodies against Hepatitis C, HIV, and VDRL core proteins.
Health assessment other than healthy, determined by the results of questioning, physical examination, laboratory tests: blood count, blood chemistry to assess liver and kidney function, fasting lipids and glucose, general urine test, and serology for hepatitis B and C, VDRL, HIV, and electrocardiogram.
In a subordinate relationship with the company or researcher.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Centro de Estudios Científicos y Clínicos Pharma S.A. de C.V.
Xochitepec, Morelos, 627790

Other trials in Mexico

About this study

Official title: Comparative Study to Evaluate the Relative Bioavailability Between a Fixed-dose Combination Product of 90 mg Ticagrelor/100 mg Acetylsalicylic Acid vs Administration of the Reference Monotherapies in Healthy Subjects.

Study conducted to determine and compare the relative bioavailability of two solid oral formulations (reference versus test) of the non-fixed combination of Ticagrelor 90 mg (Brilinta by AstraZeneca S.A. de C.V.) + Acetylsalicylic Acid 100 mg (ASPIRINA JUNIOR by Bayer de México S.A. de C.V.) administered concomitantly versus the fixed-dose combination of Ticagrelor 90 mg / Acetylsalicylic Acid 100 mg manufactured by Laboratorios Silanes S.A. de C.V.

Read the detailed description

Prospective, longitudinal, open-label, single-dose per period, two treatments two periods, crossover, balanced, randomized study with a 7-day washout period in 20 plus 4 (24) healthy research subjects of both genders, under fasting conditions. In order to establish characterization of the pharmacokinetic parameters Cmax, Tmax, T1/2, Ke, (AUC 0-t) and the (AUC 0-~) when administered as a single dose of the non-fixed combination of Ticagrelor 90 mg (Brilinta by AstraZeneca S.A. de C.V.) + Acetylsalicylic Acid 100 mg (ASPIRINA JUNIOR by Bayer de México S.A. de C.V.) as a reference formulation and the fixed-dose combination of Ticagrelor 90 mg/ Acetylsalicylic Acid 100 mg as the test formulation manufactured by Laboratorios Silanes S.A. de C.V.

Conditions: Healthy
Being tested: A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.), A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.)

What participants receive

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

A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.)Drug
Formula: 90 mg/ 100 mg Pharmaceutical Form: Capsule Dosage: 1 capsule (90 mg/ 100mg) Administration way: oral
A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.)Drug
A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral A3: Pharmaceutical Form: Tablet Formula: Each tablet contains 100 mg Dosage: 1 tablet of 100 mg Administration way: oral

Study groups in NCT07444164
Study group	Role	What they receive
Group A: Ticagrelor / Acetylsalicylic Acid in fixed dose combination.	Experimental	Pharmaceutical form: capsule. Each capsule contains: * Ticagrelor 90 mg * Acetylsalicylic Acid 100 mg Administration way: oral. Receives: Drug: A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.)
Group B: Ticagrelor / Group C: Acetylsalicylic acid.	Active comparator	Group B: Ticagrelor Pharmaceutical form: Tablet. Formula: Each tablet contains 90 mg of Ticagrelor. Dosage: 1 tablet of 90 mg. Administration way: Oral. Group C: Acetylsalicylic Acid. Pharmaceutical form: Tablet. Formula: Each tablet contains 100 mg of Acetylsalicylic acid. Dosage: 1 tablet of 100 mg. Administration way: Oral. Receives: Drug: A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.)

What is being measured

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

Determine Cmax.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid 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, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Determine AUC 0-t.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid 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, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Determine AUC 0-inf.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid 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, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Determine Tmax.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid employing the 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, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Determine Ke.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid 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, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Determine T1/2.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid 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, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.

Secondary outcomes (2)

Determine the frequency of occurrence of adverse events
The percentage of frequency of appearance of each adverse event was evaluated.
Measured: 1, 2, 9 and 11 days.
Adverse events
Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.
Measured: 1, 2, 9 and 11 days.

Timeline

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

13 Jan 20255 Feb 2025

First posted2 Mar 2026
Study start13 Jan 2025
Primary completion23 Jan 2025
Study completion5 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07444164
Sponsor's protocol ID: 01-SLN-01-TCG/ASA-24
Status last verified: Feb 2026
First submitted: 24 Feb 2026
Last updated: 2 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study to Evaluate the Relative Bioavailability Between a Fixed-dose Combination Product of 90 mg Ticagrelor/100 mg Acetylsalicylic Acid vs Administration of the Reference Monotherapies in Healthy Subjects.
ClinicalTrials.gov ID: NCT07444164
Acronym / sponsor ID: 01-SLN-01-TCG/ASA-24
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 13 Jan 2025 (actual)
Primary completion: 23 Jan 2025 (actual)
Study completion: 5 Feb 2025 (actual)
First posted: 2 Mar 2026 (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: 2

Arm	Type	Receives
Group A: Ticagrelor / Acetylsalicylic Acid in fixed dose combination.	Experimental	Drug: A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.)Pharmaceutical form: capsule. Each capsule contains: * Ticagrelor 90 mg * Acetylsalicylic Acid 100 mg Administration way: oral.
Group B: Ticagrelor / Group C: Acetylsalicylic acid.	Active comparator	Drug: A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.)Group B: Ticagrelor Pharmaceutical form: Tablet. Formula: Each tablet contains 90 mg of Ticagrelor. Dosage: 1 tablet of 90 mg. Administration way: Oral. Group C: Acetylsalicylic Acid. Pharmaceutical form: Tablet. Formula: Each tablet contains 100 mg of Acetylsalicylic acid. Dosage: 1 tablet of 100 mg. Administration way: Oral.

Who may qualify

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

Key inclusion criteria (16 listed)

Subjects who have given informed consent in writting
Subjects of both genders aged between 18 and 55 years, mexicans, with no background of hypersensitivity or allergies to the drugs under study or related drugs.
Subjects with no background of using anticoagulants of any kind.
Subjects with no background of hepatitis B and/or C.
Vital signs within normal limits, according to international guidelines recorded during selection.

Key exclusion criteria (14 listed)

Individuals with hypersensitivity to ticagrelor, acetylsalicylic acid, or any of their components.
Subjects with background of use of anticoagulants.
Subjects with background of hepatitis B and/or C.
Vital signs outside normal limits, according to international guidelines recorded during selection.
Electrocardiogram showing evidence of conduction disturbances, with RR, PR, QRS, and QT intervals and ST segment values within physiological limits.

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: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.)Formula: 90 mg/ 100 mg Pharmaceutical Form: Capsule Dosage: 1 capsule (90 mg/ 100mg) Administration way: oral	Drug	Group B: Ticagrelor / Group C: Acetylsalicylic acid.
A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.)A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral A3: Pharmaceutical Form: Tablet Formula: Each tablet contains 100 mg Dosage: 1 tablet of 100 mg Administration way: oral	Drug	Group A: Ticagrelor / Acetylsalicylic Acid in fixed dose combination.

Primary outcome

Determine Cmax.
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.
Determine AUC 0-t.
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.
Determine AUC 0-inf.
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid employing the area under the curve from time zero to infinity calculated (AUC 0-inf).
Determine Tmax.
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid employing the time of the maximum measured concentration (tmax) obtained graphically from the plasma concentration profile with respect to time.
Determine Ke.
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid 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).
Determine T1/2.
Time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.
Evaluate the pharmacokinetics profile of the fixed dose Ticagrelor/Acetylsalicylic Acid employing the half time elimination (t1/2) by the quotient of Ln(2) Ke.

2 secondary outcomes

Determine the frequency of occurrence of adverse events
Time frame: 1, 2, 9 and 11 days.
Adverse events
Time frame: 1, 2, 9 and 11 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 2 Mar 2026.
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.

Susana Tera - Ponce, Dr. principal investigator

Centro de Estudios Científicos y Clínicos Pharma S.A. de C.V.

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 16 inclusion and 14 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 2 Mar 2026. 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?

Determine Cmax. (time frame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.0 and 48.0 hours.). The study lists 6 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 NCT07444164.

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 2 Mar 2026.