Clinical Trial Details
| Trial ID: | L6248 |
| Source ID: | NCT06063109 |
| Associated Drug: | Thp-00101 (Dapagliflozin) 10mg |
| Title: | A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Hypertension|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: THP-00101 (Dapagliflozin) 10mg|DRUG: THP-00102 (Telmisartan) 80mg |
| Outcome Measures: | Primary: Pharmacokinetics - AUCτ,ss, AUCτ,ss of Dapagliflozin \& Telmisartan, Day 1 to Day 11|Pharmacokinetics - Cmax,ss, Cmax,ss of Dapagliflozin \& Telmisartan, 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, Day 1 to Day 17 | Secondary: Pharmacokinetics - Tmax,ss, Tmax,ss of Dapagliflozin \& Telmisartan, Day 1 to Day 11|Pharmacokinetics - Cmin,ss, Cmin,ss of Dapagliflozin \& Telmisartan, Day 1 to Day 11|Pharmacokinetics - CLss/F, CLss/F of Dapagliflozin \& Telmisartan, Day 1 to Day 11|Pharmacokinetics - Vdss/F, Vdss/F of Dapagliflozin \& Telmisartan, Day 1 to Day 11|Pharmacokinetics - PTF, Peak-trough Fluctuation of Dapagliflozin \& Telmisartan, Day 1 to Day 11 |
| Sponsor/Collaborators: | Sponsor: THPharm Corp. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 51 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2023-10-09 |
| Completion Date: | 2023-11-09 |
| Results First Posted: | |
| Last Update Posted: | 2023-11-22 |
| Locations: | H Plus Yangji Hospital, Seoul, 08779, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT06063109 |
