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CompletedNCT06063109Updated Nov 22, 2023

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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 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

02

Conditions studied

  • Hypertension
  • Diabetes Mellitus, Type 2
03

In context

Hypertension

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. A person who is 19 years of age or older at the screening visit
  2. 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

  3. A person who has no clinically meaningful congenital or chronic disease and has no pathological symptoms or findings as a result of medical examination at a screening visit
  4. A person who has been determined to be suitable for the test as a result of diagnostic tests such as hematology tests, hematochemical tests, serum tests, urine tests, etc., set and conducted by the test manager (or delegated test doctor) according to the characteristics of clinical drugs
  5. 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

  6. A person who has received and understood sufficient explanation of the purpose, contents, characteristics of clinical trial drugs, expected abnormal cases, etc., and signed the consent form according to his/her free will

Exclusion criteria

Exclusion Criteria:

  1. A person who has or has a history of clinically significant diseases corresponding to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary system, mental and nervous system, musculoskeletal system
  2. A person who has a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) or has gastrointestinal diseases that may affect drug absorption
  3. Those who have taken drug metabolism-inducing and inhibiting drugs such as barbital drugs within one month of the first administration date, or drugs that may interfere with this clinical trial within 10 days of the first administration (however, in consideration of pharmacokinetic and pharmacokinetic characteristics of combination drugs it may consider as possible)
  4. A person who participates in other clinical trials or biological equivalence tests within six months of the first administration and administered clinical trial drugs
  5. A person who has donated whole blood within 8 weeks of the first administration, donated ingredients within 2 weeks or received a blood transfusion within 4 weeks from the first administration
  6. A person who meets the following conditions within one month of the first dose date

    • Men consume an average of 21 cups/week of alcohol
    • Women consume an average of 14 cups/week of alcohol

      (1 glass = 50mL of soju, 30mL of spirits, or 250mL of beer)

    • An average of more than 20 cigarettes a day
  7. A patient who falls under the following

    • Patients with a history of hypersensitivity to the main ingredient or additive of this drug
    • Type 1 diabetes patient with diabetic ketoacidosis
    • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
    • A patient on dialysis
    • Patients with severe liver disorders, biliary obstruction, or bile congestion (mostly this drug is excreted as bile). A decrease in liver cleaning rate can be expected in patients with bile congestion, biliary obstruction disease, or liver failure.)
    • Patients with hereditary angioedema, or patients with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists
    • Combination with aliskiren-containing preparations in patients with diabetes or moderate to severe renal disabilities (glomerular filtration rate \<60mL/min/1.73m2)
  8. For reasons other than the above selection and exclusion criteria, the person in charge of testing (or the delegated test doctor) determines that he/she is not suitable for participation in this clinical trial
  9. In the case of female volunteers, those suspected of being pregnant or nursing
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study 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

    Drug: THP-00101 (Dapagliflozin) 10mg · Drug: THP-00102 (Telmisartan) 80mg

  • 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

    Drug: THP-00101 (Dapagliflozin) 10mg · Drug: THP-00102 (Telmisartan) 80mg

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics - AUCτ,ss

    AUCτ,ss of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

  2. Pharmacokinetics - Cmax,ss

    Cmax,ss of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

  3. 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

Secondary outcomes

  1. Pharmacokinetics - Tmax,ss

    Tmax,ss of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

  2. Pharmacokinetics - Cmin,ss

    Cmin,ss of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

  3. Pharmacokinetics - CLss/F

    CLss/F of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

  4. Pharmacokinetics - Vdss/F

    Vdss/F of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

  5. Pharmacokinetics - PTF

    Peak-trough Fluctuation of Dapagliflozin \& Telmisartan

    Time frame: Day 1 to Day 11

07

Study locations

1 site
  • H Plus Yangji Hospital
    Seoul, 08779, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06063109
Lead sponsor
THPharm Corp.
Responsible party
Sponsor
First posted
Oct 2, 2023
Start date
Oct 9, 2023
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023
Last update
Nov 22, 2023

Study contacts

Seung Hyun Kang, M.D
principal investigator · H Plus Yangji Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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

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