Why the study?
Does concomitant administration of clopidogrel and dabigatran etexilate alter the pharmacokinetic and pharmacodynamic profiles of either agent in healthy male volunteers?
Population
44 healthy male volunteers aged 18-40 years, BMI 18.5-29.9 kg/m2, with no gastrointestinal, hepatic, renal…
Comparison
Concomitant administration of clopidogrel and… vs Dabigatran etexilate 150 mg twice daily alone…
Design
RCT, randomized, multiple-dose, crossover study (Part 2), open-label
Follow-up
up to 5 days per treatment period
Authors
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Supports co-administration without dose adjustment; confirms absence of clinically relevant pharmacokinetic interaction.
Does concomitant administration of clopidogrel and dabigatran etexilate alter the pharmacokinetic and pharmacodynamic profiles of either agent in healthy male volunteers?
Concomitant administration of dabigatran etexilate and clopidogrel at clinically relevant doses does not significantly alter the pharmacokinetic or pharmacodynamic profiles of either agent.
Härtter et al. (2012) studied this question.
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