Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-HCR21 and IY-MIC

NCT06471868 | Active Not Recruiting Phase 1

• 1 other identifier: IY-HTBC01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the pharmacokinetic and safety of IY-HCR21

Conditions

Pharmacokinetics

Keywords

a parasympathomimetic choline carbamate

Outcome Measures

Primary Outcomes (2)

• Betanechol AUCt,ss

  Betanechol AUCt,ss(Area under the plasma drug concentration-time curve in steady state)

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

• Betanechol Cmax,ss

  Betanechol Cmax,ss (Maximum plasma concentration in steady state)

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

Secondary Outcomes (6)

• AUCinf

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

• t1/2

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

• Tmax,ss

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

• AUCt/AUCinf

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

• AUC24

  Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24)

Study Arms (2)

A group

ACTIVE COMPARATOR

Period 1 : IY-HCR21 1Tab, BID Period 2 : IY-MIC 1Tab, QID

Drug: IY-HCR21; Drug: IY-MIC

B group

ACTIVE COMPARATOR

Period 1 : IY-MIC 1Tab, QID Period 2 : IY-HCR21 1Tab, BID

Drug: IY-HCR21; Drug: IY-MIC

Interventions

IY-HCR21 DRUG

Betanechol 50mg

A group; B group

IY-MIC DRUG

Betanechol 25mg

A group; B group

Eligibility Criteria

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

You may qualify if:

• Volunteers aged 19 years and above at screening
• A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)\* of ≥18.0 and ≤ 30 at screening
• \*BMI(body mass index, kg/m\^2)= Body weight (kg)/\[height (m)\^2\]
• No clinically significant congenital or treatment-requiring chronic medical conditions and no pathological symptoms or findings on internal medicine examination (including EEG, electrocardiogram, thoracic and gastroscopy or gastrointestinal radiology, if necessary)
• A person who is determined by the principal investigator (or a physician delegated by the principal investigator) to be suitable as a patient as a result of diagnostic tests (e.g., haematology, blood chemistry, serology, urinalysis) and electrocardiograms (ECG) set and conducted according to the characteristics of the investigational drug at the time of screening.
• Agree that they or their spouse or partner is using a medically accepted method of contraception\* (but not hormonal agents) to exclude the possibility of pregnancy from the date of the first dose of investigational drug until 7 days after the last dose of investigational drug, and agree not to provide sperm or eggs
• Signed the consent form freely and voluntarily after being fully informed and understanding the purpose, content, characteristics of the investigational drug, and expected adverse events of this study.

You may not qualify if:

• Have taken drugs that induce or inhibit drug metabolising enzymes, such as barbiturates, within 30 days prior to study entry (first dose day) or have taken drugs that may interfere with this study within 10 days prior to study entry (first dose day)
• Participated in a bioequivalence study or other clinical trial within 6 months prior to study initiation (first dose) and received an investigational product
• blood donation within 8 weeks prior to study entry (first dose day) or component donation within 2 weeks
• Have a history of gastrointestinal surgery (except appendectomy and hernia surgery) that may affect the absorption of the drug
• Excessive alcohol consumption within 1 month prior to study entry (first dose day)
• Patients with any of the following conditions
• Patients with mechanical obstruction of the gastrointestinal tract or urinary tract
• spastic gastrointestinal diseases, stomach ulcers, acute inflammatory diseases of the gastrointestinal tract
• Patients with peritonitis
• Patients with vasovagal dystonia
• Patients with asthma
• Patients with hyperthyroidism
• Patients with coronary artery occlusion
• Bradycardia, atrioventricular conduction disorder, vasomotor instability
• Hypotension, hypertension

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

H plus Yangji Hospital

Seoul, Gwanak-gu, 08756, South Korea

Location

Study Officials

• Seung Hyun Kang, MD, PhD

  H Plus Yangji Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: June 10, 2024
• Primary Completion: June 25, 2024
• Study Completion: July 2, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

KR (1)