Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: HIP2105; Drug: RLD2104

Detailed Description

A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jin-A Jung, Ph.D.; Phone Number: 82-2-410-9038; Email: jajung@hanmi.co.kr
• Study Contact Backup: Name: In-Jin Jang, M.D.; Phone Number: 82-2-2072-1910; Email: ijjang@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers in the age between 19 and 50 years old.
• Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
• After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
• Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

• Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
• Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
• Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
• Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
• Heavy smoker (>10 cigarettes/day).

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
Experimental: Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1; Period 1: RLD2104 Period 2: HIP2105	Drug: HIP2105; Test drug; Drug: RLD2104; Reference drug
Experimental: Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2; Period 1: HIP2105 Period 2: RLD2104	Drug: HIP2105; Test drug; Drug: RLD2104; Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCtau	0-24hours
changed rate from baseline in 24h integrated gastric pH	0-24hours

Secondary Outcome Measures

Outcome Measure	Time Frame
AUClast	0-24hours
Cmax	0-24hours
Tmax	0-24hours
t1/2	0-24hours
CL/F	0-24hours
Vd/F	0-24hours
Cmin,ss	0-24hours
Cmax,ss	0-24hours
t1/2,ss	0-24hours
CLss/F	0-24hours
Vd,ss/F	0-24hours
Duration time with integrated gastric pH>4 / 24hr	0-24hours
Median 24 hr gastric pH	0-24hours
changed rate from baseline in 24h integrated gastric pH	0-24hours

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: In-Jin Jang, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HM-ESOB-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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