Healthy Individuals Clinical Trial
Official title:
A Single Centre, Cross-over, Single Dose, Two Period, Randomized, Open Label Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet With Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition
Single oral administration of study drugs (i.e. Anplag® & Brilinta®) in Two periods after at least 10 hours fasting. The periods will be separated by a washout period of 7 days. The purpose of this study is to compare the bioavailability of Anplag® 90mg (Ticagrelor) Tablet with Brilinta® 90 mg (Ticagrelor) Tablet under fasting conditions in healthy Pakistani male subjects.
The subjects will be randomly assigned in period 1 to T or R sequence and will be administered the study drugs T (Anplag® 90 mg) or R (Brilinta® 90 mg) with 240 mL ambient temperature water following at least 10 hours fasting. Blood samples will be withdrawn at pre-determined time points for estimation of plasma drug concentration upto 48 hours post dose. the subjects will be crossed over in Period 2 separated by a washout period of 7 days and administered RT sequence in period 2. Similar procedure of blood sampling will be applied for estimation of plasma drug concentration upto 48 hours post dose. ;
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