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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: HIP2105; Drug: RLD2104

• Registration Number: NCT04975711
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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 Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-23
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2	HIP2105	Period 1: HIP2105 Period 2: RLD2104
Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1	HIP2105	Period 1: RLD2104 Period 2: HIP2105
Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2	RLD2104	Period 1: HIP2105 Period 2: RLD2104
Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1	RLD2104	Period 1: RLD2104 Period 2: HIP2105

Primary Outcome Measures

Name	Time	Method
AUCtau	0-24hours
changed rate from baseline in 24h integrated gastric pH	0-24hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of