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

NCT06063109 | Completed Phase 1

• 1 other identifier: THP-001-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Pharmacokinetics - Tmax,ss

  Day 1 to Day 11

• Pharmacokinetics - Cmin,ss

  Day 1 to Day 11

• Pharmacokinetics - CLss/F

  Day 1 to Day 11

• Pharmacokinetics - Vdss/F

  Day 1 to Day 11

• Pharmacokinetics - PTF

  Day 1 to Day 11

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Telmisartan

EXPERIMENTAL

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

THP-00101 (Dapagliflozin) 10mg DRUG

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

Dapagliflozin; Telmisartan

THP-00102 (Telmisartan) 80mg DRUG

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

Dapagliflozin; Telmisartan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• THPharm Corp.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seung Hyun Kang, M.D

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 2, 2023
• Study Start: October 9, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)