Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B

NCT06618079 | Active Not Recruiting Phase 1

• 1 other identifier: HUC2-565_P1_DDI
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• AUCtau,ss

  Pharmacokinetic parameter

  0-14days

• Cmax,ss

  Pharmacokinetic parameter

  0-14days

Secondary Outcomes (9)

• AUCinf,ss

  0-14days

• Tmax,ss

  0-14days

• T1/2,ss

  0-14days

• CLss/F

  0-14days

• Vdss/F

  0-14days

Study Arms (2)

Cohort A

EXPERIMENTAL

Evaluate the effect of S-Amlodipine on the pharmacokinetic properties of Azilsartan under steady states.

Drug: HUC2-565-A, HUC2-565-A and HUC2-565-B

Cohort B

EXPERIMENTAL

Evaluate the effect of Azilsartan on the pharmacokinetic properties of S-amlodipine under steady states.

Drug: HUC2-565-B, HUC2-565-A and HUC2-565-B

Interventions

HUC2-565-A, HUC2-565-A and HUC2-565-B DRUG

Cohort A received HUC2-565-A for 5 days, followed by HUC2-565-A and HUC2-565-B for 9 days.

Cohort A

HUC2-565-B, HUC2-565-A and HUC2-565-B DRUG

Cohort B takes HUC2-565-B for 9 days, then HUC2-565-A and HUC2-565-B for 5 days.

Cohort B

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteer aged 19 years or older at the pre-study(screening)
• Volunteer with a body mass index(BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less, with a 50kg or more weight at the pre-study(screening)
• A person who has no chronic disease requiring birth or treatment and has no pathological symptoms or findings as a result of medical examination
• Volunteer who is judged to be suitable as a clinical trial subject as a result of screening test within 28 days of the first administration of the investigational product.
• A person who, after hearing and fully understanding the details of this clinical trial, voluntarily decides to participate and agrees to comply with the compliance of the test subjects during the clinical trial period

You may not qualify if:

• Current or past medical history of the liver, kidney, nervous system, respiratory system, endocrine system, blood disease, tumor, Urogenital system, cardiovascular system, digestive system, musculoskeletal system, etc., which are clinically significant, in addition to current symptoms or past medical history.
• Person with a history of gastrointestinal diseases(Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery(except for simple appendectomy or hernia surgery) that may affect Investigational product absorption
• Pregnant women(Urine-HCG positive person) or breastfeeding mother
• Person with a history of hypersensitivity(anaphylaxis or angioedema, etc) or clinically significant hypersensitivity reactions to drugs, formulation additives, and other drugs(aspirin, penicillin antibiotics, macrolide antibiotics, etc), including components Azilsartan and S-amlodipine
• Those who have clinically significant findings, including the following findings on 12-lead electrocardiogram test(screening)
• in case of men QTc \> 450ms, in case of women QTc \> 470ms
• PR interval \> 200ms
• QRS duration \> 120ms
• Those who show clinically significant results on the clinical laboratory examination, including the following results(screening)
• Those whose AST, ALT, ALP, r-GT and Bilirubin total exceed twice the upper limit of the normal range in the clinical laboratory test for liver function evaluation.
• If the level of creatine in the blood is outside the reference range or the eGFR calculated by the CKD-EPI formula is less than 60mL/min/1.73m2
• Those whose blood total cholesterol and LDL-cholesterol levels exceed 1.5 times the upper limit of the normal range
• Clinical laboratory examination in which CPK exceeds 2.5 times the upper limit of the normal range
• A person with a history of substance abuse or who has tested positive for substance abuse in a urine drug test.
• A person whose blood pressure and pulse rate fall within the following range in the vital signs measured from the upper left after resting for at least 3 minutes during screening

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Chungbuk national university hospital

Jungbuk, 28644, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Gyu Park

  Chungbuk National University 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

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: October 1, 2024
• Study Start: April 20, 2024
• Primary Completion: July 12, 2024
• Study Completion: October 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)