Why the study?
To evaluate the pharmacokinetics, bioequivalence, and safety profiles of test and reference 90 mg ticagrelor tablets and their metabolite AR-C124910XX under fasting and fed conditions.
Does the test drug of 90 mg ticagrelor tablets demonstrate bioequivalence and similar safety to the reference drug in healthy Chinese subjects under fasting and fed conditions?
Does the test drug of 90 mg ticagrelor tablets demonstrate bioequivalence and similar safety to the reference drug in healthy Chinese subjects under fasting and fed conditions?
The test and reference 90 mg ticagrelor tablets are bioequivalent with similar pharmacokinetic and safety profiles in healthy Chinese subjects, regardless of food intake.
Answers are grounded in this paper and cite their sources.
Bioequivalence supports potential substitution of test 90 mg ticagrelor; extends data to Chinese subjects under fasting/fed conditions.
PURPOSE: To evaluate the pharmacokinetics (PK), bioequivalence and safety profiles of test drug and reference drug of 90 mg ticagrelor tablets and their main active metabolite AR-C124910XX under fasting and fed conditions. METHODS: ). Bioequivalence was judged by whether the 90% confidence intervals (CIs) of the geometric mean ratio (GMR) of the test/reference drugs were within the predefined range of 80-125%. Adverse events (AEs) were assessed as safety endpoints. RESULTS: all fell within 80%-125% regardless of food intake or not. No severe adverse events were observed in the study. Chinese clinical trial registration number is ChiCTR1800015091 (http://www.chictr.org.cn). CONCLUSION: Our results demonstrated that the test drug and the reference drug of ticagrelor tablets were bioequivalent. The PK and safety profiles were also similar regardless of food intake or not in healthy Chinese subjects.
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Wang et al. (2021) studied this question.
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