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.)
To statistically compare the bioavailability of rosuvastatin 20 mg and ezetimibe 10 mg in a pharmacokinetic non-interference study, after single-dose oral administration of a product with the fixed combination of active ingredients with respect to the individual components administered separately in healthy volunteers fasting. In the same way, the safety of the presentations will be evaluated based on the registry of adverse events at the end of the three study periods. The classic 90% confidence intervals will be determined for the intra-individual ratios (test / reference) of the main parameters AUC0-t, AUC0-inf, Cmax for rosuvastatin and ezetimibe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Form: Tablets Dosage: 20 mg Adminstration way: Oral
Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration way: Oral
Pharmaceutical Form: Tablets Dosage: 10 mg Adminstration way: Oral
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
Maximum observed concentration following the treatment (Cmax
Evaluate the fixed dose pharmacokinetics profile of rosuvastatin/ezetimibe, employing the maximum observed concentration following the treatment (Cmax)
Time frame: 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
Evaluate the fixed dose pharmacokinetics profile of rosuvastatin/ezetimibe, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method.
Time frame: 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),
Evaluate the fixed dose pharmacokinetics profile of rosuvastatin/ezetimibe, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).
Time frame: 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).
Evaluate the fixed dose pharmacokinetics profile of Rosuvastatin/ezetimibe, employing time of the maximum measured concentration (Tmax).
Time frame: 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
Sitting blood pressure (mmHg).
The sitting blood pressure was measured and registered at case format report throughout the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours
Pulse rate (p/m).
The pulse rate was measured and registered at case format report throughout the study.
Time frame: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours
Respiratory rate (rr).
The respiratory rate was measured and registered at case format report throughout the study.
Time frame: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours
Axillary-body temperature (°C).
The axillary-body temperature was measured and registered at case format report throughout the study.
Time frame: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours
Adverse events
Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.
Time frame: 96 hours