Monocentric study of no pharmacokinetic interaction between rosuvastatin 20 mg and ezetimibe 10 mg. An open design, randomized, single dose with three periods, six sequences and crossed, in healthy volunteers with fasting conditions, managed in fixed dose combination (Sponsor Laboratorios Silanes S.A. de C.V.) versus individual components managed by separated (Crestor®, product of Astrazeneca, S.A. de C.V and Ezetrol®. product of Undra S.A. de C.V.)
Age range
18 Years – 55 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum observed concentration following the treatment (Cmax
Timeframe: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours
The area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method
Timeframe: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours
The area under the curve from time zero to infinity calculated (AUC 0-inf),
Timeframe: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours
Time of the maximum measured concentration (Tmax).
Timeframe: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours