The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each alone in healthy male subjects.
This study is a randomized, open-label, three-treatment, three-period, three-sequence and crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics after the multiple administration of LC15-0444 and pioglitazone concomitantly or each alone. Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks(-21 d \~ -2 d) before drug administration(1 d). Eligible subjects will be randomized to one of three sequence groups. According to the characteristics of anti-diabetic drugs, it is expected to be administered with other anti-diabetic drugs. Therefore, Drug-Drug Interaction with Pioglitazone should be identified in this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
LC15-0444 200 mg (100 mg x 2) qd (12 days once daily) Pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) LC15-0444 200 mg (100 mg x 2) qd + pioglitazone 30 mg (15 mg x 2) qd (12 days once daily)
Seoul National University Hospital
Seoul, South Korea
AUCτ,ss, Cmax,ss of LC15-0444 and pioglitazone
Time frame: During all dosing visits
Tmax,ss, t1/2, CL/F, Aeτ,ss, CLR, Ctrough,ss of LC15-0444 and pioglitazone AUCτ,ss, Cmax,ss, metabolic ratio of LC15-0444, Pioglitazone metabolites AUC,ss, Cmax,ss, metabolic ratio of pioglitazone metabolites
Time frame: During all dosing visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.