In order to evaluate the bioequivalence of the test preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
This single-center, randomized, open-lable, single-dose, two-cycle,cross-over design bioequivalence test was conducted in subjects under fasting conditions. Subjects were fasted for at least 10 hours overnight in each cycle,but can't ban their from drinking water.The next morning according to test-reference (TR) or Reference-test (RT) sequential oral perindopril tert-butylamine tablets (4 mg, 240 mL warm water) . Each period was separated with a 14-day washout period in fasted trials. The blood concentrations of perindopril and perindoprilat in qualified subjects were tested. Safety assessment includes vital signs examination, physical examination, laboratory safety examination, coagulation examination, electrocardiogram and adverse event reports.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
32
The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
General Hospital of the northern theater of the Chinese people's Liberation Army
Shenyang, Liaoning, China
Maximum drug concentration (Cmax) of Perindopril
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Area under the plasma concentration versus time curve (AUC0-∞、AUC0-t)of Perindopril
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Time to reach maximum plasma concentration(Tmax) of Perindopril and Perindoprilat
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Terminal elimination half-life(t1/2 )of Perindopril and Perindoprilat
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Maximum drug concentration (Cmax) of Perindoprilat
Time frame: fore administration (within 2 hours) and 10 minutes to 72 hours after administration
Area under the plasma concentration versus time curve (AUC0-∞、AUC0-t)of Perindoprilat
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
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