A cross over bioequivalence study of Rivaroxaban 20 mg tab compared to Xarelto 20 mg tab manufactured by Bayer 24 healthy volunteers under fasting condition

Comparison of bioavailability of rivaroxaban after single dose of 20 mg tablet made by Pars Daroo and Bayer

The study is cross-over. 24 healthy volunteers randomly receive one of the two test or reference drugs in each phase of the study, a total of 13 blood samples is received from the individual

On the sampling day, after 10 hours fasting, the volunteers will take a single dose of 20 mg test or reference drug with 240 ml of water, and blood saomples are taken at times of 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 24 and 30 hours after drug administration, then samples are transferred to -70 freezer after plasma separation finally the plasma drug concentration is determined according to LCMSMS method. After a wash out period of week in the second phase, the candidates who received the test drug in the first phase will receive the reference sample, and the people who had previously received the reference sample will receive the test sample in the second phase.

Healthy male volunteers without a history of heart, liver, kidney, lung, coagulation disorders and people who have not taken any medication since one month before the study also have systolic blood pressure above 13 and below 10 and diastolic blood pressure below 6 and above From 85 mm Hg, heart rate not more than 90 or less than 60 beats per minute,

Blood concentration of rivaroxaban of Pars Darou is compared to Bayer product

Plasma concentration of test and reference drug

Each volunteer is assigned a code. In this way, half of the codes in the first phase of sampling receive the test drug and half of them receive reference drug, and in the second phase of the study, vice versa. The group that took the test drug in the first phase will take the reference drug in the second phase and the group that received the reference drug in the first phase will take the test drug.

The drug (test or reference drug) is removed from the original packaging the day before the study and packaged in small disposable containers. Therefore, it is not in the original packaging, none of the volunteer nor the prescriber know which drug is being delivered.

Pars Daroo factory may not allow us to publish data.