Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2025-12-17 @ 3:14 AM
Study NCT ID:
NCT06063109
Status:
None
Last Update Posted:
2023-11-22 00:00:00
First Post:
2023-09-08 00:00:00
Brief Title:
A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.
Sponsor:
THPharm Corp
Organization:
THPharm Corp.
Study Overview
Official Title:
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of THP-00101 and THP-00102 in Healthy Adult Volunteers
Status:
None
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 tablet5 days Treatment B THP-00101 Dapagliflozin 1 tablet5 days THP-00102 Telmisartan 1 tablet5 days
Telmisartan 32 Subjects Tx C 5 days - Tx C 5 days Treatment C THP-00102 Telmisartan 1 tablet5 days Treatment B THP-00102 Telmisartan 1 tablet5 days THP-00101 Dapagliflozin 1 tablet5 days
Dapagliflozin 18 Subjects Tx A 5 days - Tx B 5 days Treatment A THP-00101 Dapagliflozin 1 tablet5 days Treatment B THP-00101 Dapagliflozin 1 tablet5 days THP-00102 Telmisartan 1 tablet5 days
Telmisartan 32 Subjects Tx C 5 days - Tx C 5 days Treatment C THP-00102 Telmisartan 1 tablet5 days Treatment B THP-00102 Telmisartan 1 tablet5 days THP-00101 Dapagliflozin 1 tablet5 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None