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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Determine Cmax.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: A2: Ticagrelor (BRILINTA®, AstraZeneca S.A. de C.V.) A3: Acetylsalicylic Acid (ASPIRINA JUNIOR®, Bayer de México S.A. de C.V.) (Drug)
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.
干预措施: A1: Ticagrelor / Acetylsalicylic acid in fixed dose combination capsule. (Laboratorios Silanes S.A. de C.V.) (Drug)
结局指标
主要结局
Determine Cmax.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Determine the frequency of occurrence of adverse events(1, 2, 9 and 11 days.)
- Adverse events(1, 2, 9 and 11 days.)