CompletedPhase 1

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

Mexico24 participantsStarted 2025-01-13

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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 lo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine Cmax.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Trial details

NCT IDNCT07444164

SponsorLaboratorios Silanes S.A. de C.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-23

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determine Cmax.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.