A Phase 1 interventional study of THP-00101 (Dapagliflozin) 10mg and THP-00102 (Telmisartan) 80mg in Hypertension and Diabetes Mellitus, Type 2, sponsored by THPharm Corp.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by THPharm Corp. · Phase 1, Interventional, and Treatment
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
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 51 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →THPharm Corp. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A person who weighs at least 55 kg (50 kg for women) and has a body mass index (BMI) of at least 18.0 kg/m2 and at least 30.0 kg/m2 at screening visit
☞ BMI (kg/m2) = Weight (kg)/ {Height (m)}2
A person who agrees to exclude the possibility of pregnancy using a medically recognized contraceptive method* (except hormones) and does not provide sperm or eggs from the date of first administration of the clinical trial drug to 14 days after the date of last clinical trial drug administration
*medically-accepted Contraceptive methods: a combination of intrauterine devices, vasectomy, tubular ligation, and blocking contraception (male condoms, female condoms, cervical caps, contraceptive septum, sponge, etc.) or a combination of two or more blocking contraceptives
Exclusion Criteria:
A person who meets the following conditions within one month of the first dose date
Women consume an average of 14 cups/week of alcohol
(1 glass = 50mL of soju, 30mL of spirits, or 250mL of beer)
A patient who falls under the following
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
Drug: THP-00101 (Dapagliflozin) 10mg · Drug: THP-00102 (Telmisartan) 80mg
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
Drug: THP-00101 (Dapagliflozin) 10mg · Drug: THP-00102 (Telmisartan) 80mg
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
Also known as: Forxiga Tab. 10mg
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
Also known as: Micardis Tab. 80mg
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
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dapagliflozin · Telmisartan
THPharm Corp.