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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.); Drug: A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.)

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 losing 450 mL or more of blood within 60 days prior to the study.

Exclusion Criteria:

• 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).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Ticagrelor / Acetylsalicylic Acid in fixed dose combination.; Pharmaceutical form: capsule. Each capsule contains: Ticagrelor 90 mg; Acetylsalicylic Acid 100 mg Administration way: oral.	Drug: 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
Active Comparator: Group B: Ticagrelor / Group C: Acetylsalicylic acid.; 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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).	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the frequency of occurrence of adverse events	The percentage of frequency of appearance of each adverse event was evaluated.	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.	1, 2, 9 and 11 days.

Collaborators and Investigators

• Sponsor: Laboratorios Silanes S.A. de C.V.
• Investigators: Principal Investigator: Susana Tera - Ponce, Dr., Centro de Estudios Científicos y Clínicos Pharma S.A. de C.V.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Purines; Phenols; Benzene Derivatives; Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Adenosine; Purine Nucleosides; Ticagrelor; Aspirin
• Other Study ID Numbers: 01-SLN-01-TCG/ASA-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No