The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.
A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
38
Film Coated Tablets products containing 10 mg Rosuvastatin
Future Research Center (FRC)
Cairo, Egypt
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Rosuvastatin peak concentration
Time frame: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))
The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast).
Time frame: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")
Time frame: Pre-dose to infinite time
Maximum time (Tmax)
Time until Cmax is reached
Time frame: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
Elimination Rate Constant (Kel)
Kel is a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system
Time frame: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
Plasma concentration half-life (t1/2)
t1/2 is the time taken for the plasma concentration of a drug to reduce to half its original value. It is used to estimate how long it takes for a drug to be removed from your body.
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Time frame: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours