Healthy Male Volunteers Clinical Trial
Official title:
A Randomized, Open-Label, Drug-Drug Interaction Study To Evaluate The Effect Of Ketoconazole Or Rifampicin On The Pharmacokinetic Characteristics And Safety Of Lc15-0444 In Healthy Male Volunteers
A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.
This study is a randomized, open-label, 2-period, 3-treatment, 1-sequence, drug-drug
interaction study in healthy volunteers to evaluate effect of ketoconazole or rifampicin on
the PK characteristic and safety of LC15-0444.
Eligibility for participation of this study will be determined by demographic information,
medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
within 4 weeks(-28 d ~ -2 d) before the first drug administration(1 d). Eligible subjects
will be randomized to one of study treatment groups.
According to the characteristics of anti-diabetic drugs, it is expected to be administered
with other drugs in many patients. Therefore, Drug-Drug Interaction with CYP3A4 inducer and
inhibitor should be identified in this trial.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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