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

An Open-label, Randomized, Multiple-dose, 2-sequence, 2-period, Crossover, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetics of IY-HCR21 Compared to IY-MIC in Healthy Adult Volunteers

This study evaluate the pharmacokinetic and safety of IY-HCR21

Study Overview

• Status: Active, not recruiting
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: IY-HCR21; Drug: IY-MIC

Detailed Description

Phase 1 study to evaluate the safety and the pharmacokinetics of IY-HCR21 in healthy adult volunteers under multiple-dose condition

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 08756
      • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Volunteers aged 19 years and above at screening

2. 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]

3. 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)
4. 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.
5. 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
6. 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.

Exclusion Criteria:

1. 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)
2. Participated in a bioequivalence study or other clinical trial within 6 months prior to study initiation (first dose) and received an investigational product
3. blood donation within 8 weeks prior to study entry (first dose day) or component donation within 2 weeks
4. Have a history of gastrointestinal surgery (except appendectomy and hernia surgery) that may affect the absorption of the drug
5. Excessive alcohol consumption within 1 month prior to study entry (first dose day)

6. 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
   • Patients with myocardial infarction, severe heart disease
   • Patients with epilepsy and parkinsonism
   • Patients treated with anticholinesterase agents
   • Patients with unhealed gastrointestinal anastomoses
   • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
   • Patients who are hypersensitive to or have a history of allergy to Yellow No. 4 (tartrazine)
   • Patients with a history of hypersensitivity to any of the main ingredients or excipients of this medicine
7. Have a history of clinically significant psychiatric disorders
8. For reasons other than the above inclusion/exclusion criteria, the principal investigator (or delegated investigator) deems the subject unsuitable for this study.
9. For female volunteers, suspected pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A group; Period 1 : IY-HCR21 1Tab, BID Period 2 : IY-MIC 1Tab, QID	Drug: IY-HCR21; Betanechol 50mg; Drug: IY-MIC; Betanechol 25mg
Active Comparator: B group; Period 1 : IY-MIC 1Tab, QID Period 2 : IY-HCR21 1Tab, BID	Drug: IY-HCR21; Betanechol 50mg; Drug: IY-MIC; Betanechol 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Betanechol AUCinf(Area under the plasma drug concentration-time curve from time 0 to infinity)	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	Betanechol t1/2(Terminal half-life)	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	Betanechol Tmax,ss(Time to 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)
AUCt/AUCinf	Betanechol 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	Betanechol AUC24 (Area Under the Plasma Concentration-Time curve in 24hour)	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)
Cmin,ss	Betanechol Cmin,ss (Minimum 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)

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Study Director: Seung Hyun Kang, MD, PhD, H plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): June 25, 2024
• Study Completion (Estimated): July 2, 2024

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: a parasympathomimetic choline carbamate
• Other Study ID Numbers: IY-HTBC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No