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HypertensionPhase 1NCT06063109

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

A Phase 1 study testing THP-00101 (Dapagliflozin) 10mg and THP-00102 (Telmisartan) 80mg in people with Hypertension and Diabetes Mellitus, Type 2, run by THPharm Corp. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension, Diabetes Mellitus, Type 2
What is being tested?
THP-00101 (Dapagliflozin) 10mg and THP-00102 (Telmisartan) 80mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteSouth Korea
Study dates
9 Oct 2023to 9 Nov 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A person who is 19 years of age or older at the screening visit
  • 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 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
  • 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
  • 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
  • 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

Who cannot join

  • 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
  • A person who has a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) or has gastrointestinal diseases that may affect drug absorption
  • 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)
  • A person who participates in other clinical trials or biological equivalence tests within six months of the first administration and administered clinical trial drugs
  • 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
  • A person who meets the following conditions within one month of the first dose date
Show all 20Show fewer
  • 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
  • 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)
  • 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
  • In the case of female volunteers, those suspected of being pregnant or nursing

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • H Plus Yangji Hospital

    Seoul, 08779

Other trials in South Korea

About this study

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

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

Being tested
THP-00101 (Dapagliflozin) 10mg, THP-00102 (Telmisartan) 80mg
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THP-00101 (Dapagliflozin) 10mgDrug

    Also called Forxiga Tab. 10mg

    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) 80mgDrug

    Also called Micardis Tab. 80mg

    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 groups in NCT06063109
Study groupRoleWhat they receive
DapagliflozinExperimentalTHP-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
Receives: Drug: THP-00101 (Dapagliflozin) 10mg; Drug: THP-00102 (Telmisartan) 80mg
TelmisartanExperimentalTHP-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
Receives: Drug: THP-00101 (Dapagliflozin) 10mg; Drug: THP-00102 (Telmisartan) 80mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics - AUCτ,ss

    AUCτ,ss of Dapagliflozin \& Telmisartan

    Measured: Day 1 to Day 11

  2. Pharmacokinetics - Cmax,ss

    Cmax,ss of Dapagliflozin \& Telmisartan

    Measured: 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

    Measured: Day 1 to Day 17

Secondary outcomes (5)

  1. Pharmacokinetics - Tmax,ss

    Tmax,ss of Dapagliflozin \& Telmisartan

    Measured: Day 1 to Day 11

  2. Pharmacokinetics - Cmin,ss

    Cmin,ss of Dapagliflozin \& Telmisartan

    Measured: Day 1 to Day 11

  3. Pharmacokinetics - CLss/F

    CLss/F of Dapagliflozin \& Telmisartan

    Measured: Day 1 to Day 11

  4. Pharmacokinetics - Vdss/F

    Vdss/F of Dapagliflozin \& Telmisartan

    Measured: Day 1 to Day 11

  5. Pharmacokinetics - PTF

    Peak-trough Fluctuation of Dapagliflozin \& Telmisartan

    Measured: Day 1 to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start9 Oct 2023
  3. Primary completion9 Nov 2023
  4. Study completion9 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A two-arm, open-label, single-sequence, multiple oral dosings, crossover clinical trials 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 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
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063109
Sponsor's protocol ID
THP-001-001
Status last verified
Sep 2023
First submitted
8 Sep 2023
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing THP-00101 (Dapagliflozin) 10mg and THP-00102 (Telmisartan) 80mg in people with Hypertension and Diabetes Mellitus, Type 2, run by THPharm Corp. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics - AUCτ,ss (time frame: Day 1 to Day 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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