A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.

Sponsor
THPharm Corp.
Study ID
NCT06063109
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • THP-00101 (Dapagliflozin) 10mg — DRUG
    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
  • THP-00102 (Telmisartan) 80mg — DRUG
    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

Study Details

The study was designed to evaluate the safety and pharmacokinetic interaction between THP-00101 and THP-00102 in healthy adult volunteers.

Key Dates

Start date
Oct 9, 2023
Status verified
Sep 2023
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    THP-00101 (Dapagliflozin) 10mg (18 Subjects): Tx A (5 days) -\> Tx B (5 days) Treatment A: THP-00101 (Dapagliflozin) 10mg/5 days Treatment B: THP-00101 (Dapagliflozin) 10mg/5 days + THP-00102 (Telmisartan) 80mg/5 days
  • Experimental: Telmisartan
    THP-00102 (Telmisartan) 80mg (32 Subjects): Tx C (5 days) -\> Tx B (5 days) Treatment C: THP-00102 (Telmisartan) 80mg/5 days Treatment B: THP-00102 (Telmisartan) 80mg/5 days + THP-00101 (Dapagliflozin) 10mg/5 days

Primary Outcome Measure

Pharmacokinetics - AUCτ,ss [ Time Frame: Day 1 to Day 11 ]

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