2023
Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial
Zhou Q, Wang Z, Wang H, Chen Z, Li X, Dai X, Zhang Y, Yu X, Zhou R, Hu W. Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. American Journal Of Cardiovascular Drugs 2023, 23: 101-112. PMID: 36622539, DOI: 10.1007/s40256-022-00562-5.Peer-Reviewed Original ResearchConceptsHealthy Chinese volunteersMultiple ascending dosesChinese volunteersDose titrationAdverse eventsPharmacodynamic profileSequential cohortsDose-escalation phase I trialTarget international normalized ratioTreatment-related adverse eventsSerious adverse eventsPhase I trialInternational normalized ratioTarget rangeHealthy Chinese populationAscending dosesI trialNormalized ratioStable anticoagulationTecarfarinCohortChinese populationTolerabilityEarly withdrawalVolunteers
2021
Bioequivalence and Pharmacokinetic Evaluation of Two Oral Formulations of Regorafenib: An Open-Label, Randomised, Single-Dose, Two-Period, Two-Way Crossover Clinical Trial in Healthy Chinese Volunteers Under Fasting and Fed Conditions
Zhang Q, Wang Z, Wu J, Zhou Z, Zhou R, Hu W. Bioequivalence and Pharmacokinetic Evaluation of Two Oral Formulations of Regorafenib: An Open-Label, Randomised, Single-Dose, Two-Period, Two-Way Crossover Clinical Trial in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Design Development And Therapy 2021, 15: 3277-3288. PMID: 34349503, PMCID: PMC8328391, DOI: 10.2147/dddt.s323169.Peer-Reviewed Original ResearchConceptsHealthy Chinese volunteersSingle oral doseChinese volunteersFed conditionsOral doseSafety profileTwo-way crossover clinical trialSimilar favourable safety profileGeometric least-squares meansOral multi-kinase inhibitorPhase 1 trialCrossover clinical trialFavorable safety profileGood safety profileNon-compartmental methodsMulti-kinase inhibitorTwo-periodOpen labelAdverse eventsSingle doseClinical trialsPharmacokinetic evaluationOral formulationRegorafenibPharmacokinetic parameters