The study was designed to evaluate the safety and pharmacokinetic interaction between THP-00101 and THP-00102 in healthy adult volunteers.
The study consists of 2 periods of THP-00101 or THP00102 administration over 5 days and combined administration of THP-00101 and THP00102 over 5 days in two arms. Dapagliflozin (18 Subjects): Tx A (5 days) -\> Tx B (5 days) Treatment A: THP-00101 (Dapagliflozin) 1 tablet/5 days Treatment B: THP-00101 (Dapagliflozin) 1 tablet/5 days + THP-00102 (Telmisartan) 1 tablet/5 days Telmisartan (32 Subjects): Tx C (5 days) -\> Tx C (5 days) Treatment C: THP-00102 (Telmisartan) 1 tablet/5 days Treatment B: THP-00102 (Telmisartan) 1 tablet/5 days + THP-00101 (Dapagliflozin) 1 tablet/5 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Dapagliflozin 10mg Tablet / 5 days in period 1 and period 2 will be given to Arm A Dapagliflozin 10mg Tablet / 5 days in period 2 will be given to Arm B
Telmisartan 80mg Tablet / 5 days in period 1 and period 2 will be given to Arm B Telmisartan 80mg Tablet / 5 days in period 2 will be given to Arm A
H Plus Yangji Hospital
Seoul, South Korea
Pharmacokinetics - AUCτ,ss
AUCτ,ss of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
Pharmacokinetics - Cmax,ss
Cmax,ss of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluate incidents rate of Adverse Event of Treatment-Emergent Adverse Event and compare concomitant medication usage
Time frame: Day 1 to Day 17
Pharmacokinetics - Tmax,ss
Tmax,ss of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
Pharmacokinetics - Cmin,ss
Cmin,ss of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
Pharmacokinetics - CLss/F
CLss/F of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
Pharmacokinetics - Vdss/F
Vdss/F of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
Pharmacokinetics - PTF
Peak-trough Fluctuation of Dapagliflozin \& Telmisartan
Time frame: Day 1 to Day 11
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