Clinical trial NCT06063109: A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Diabetes Mellitus, Type 2
Lead sponsor: THPharm Corp.
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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:

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

Primary outcomes:
measure: Pharmacokinetics - AUCτ,ss
timeFrame: Day 1 to Day 11
measure: Pharmacokinetics - Cmax,ss
timeFrame: Day 1 to Day 11
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Day 1 to Day 17
Secondary outcomes:
measure: Pharmacokinetics - Tmax,ss
timeFrame: Day 1 to Day 11
measure: Pharmacokinetics - Cmin,ss
timeFrame: Day 1 to Day 11
measure: Pharmacokinetics - CLss/F
timeFrame: Day 1 to Day 11
measure: Pharmacokinetics - Vdss/F
timeFrame: Day 1 to Day 11
measure: Pharmacokinetics - PTF
timeFrame: Day 1 to Day 11
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
affiliation: H Plus Yangji Hospital
name: Seung Hyun Kang, M.D
role: PRINCIPAL_INVESTIGATOR
References: