About this trial
This study aims to evaluate the Pharmacokinetic (PK) characteristics and safety after a single oral dose administration of IN-M00007 and IN-R00007 in healthy adult volunteers
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult volunteers aged ≥ 19 and < 60 years at screening
Body mass index(BMI) in the range of 18.0 and 30.0 kg/㎡
Body weight ≥ 50kg for male
Body weight ≥ 45kg for female
Disqualifiers
Subjects who have taken drugs which can induce(e.g, Barbiturates) or inhibit drug metabolism enzyme within 30 days prior to the start of the study(first IP administration day) or have taken medications that may affect this study within 10 days prior to the start of the study(first IP administration day)
Subjects who have participated in any other clinical study or bioequivalence study and administered IP within 6 months
Subjects who have donated whole blood within 8 weeks prior to the start of the study(first IP administration day) or have donated component blood within 2 weeks prior to the start of the study(first IP administration day)
Subjects with a history of gastrointestinal resection that may affect drug absorption(excluding appendectomy and hernia operation)
Trial design
Crossover
Treatments tested in this trial
IN-R00007
DrugSingle dose
IN-M00007
DrugSingle dose
Treatment groups
Trial outcomes
Primary outcomes
PK parameter
AUCt of Rosuvastatin
PK parameter
Cmax of Rosuvastatin
PK parameter
AUCt of Ezetimibe
PK marameter
Cmax of Ezetimibe
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: