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
1 other identifier
interventional
48
1 country
1
Brief Summary
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2021
CompletedFirst Submitted
Initial submission to the registry
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2021
CompletedOctober 25, 2023
October 1, 2023
4 months
July 15, 2021
October 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
AUCtau
0-24hours
changed rate from baseline in 24h integrated gastric pH
0-24hours
Secondary Outcomes (14)
Cmax
0-24hours
Tmax
0-24hours
t1/2
0-24hours
CL/F
0-24hours
Vd/F
0-24hours
- +9 more secondary outcomes
Study Arms (2)
Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1
EXPERIMENTALPeriod 1: RLD2104 Period 2: HIP2105
Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2
EXPERIMENTALPeriod 1: HIP2105 Period 2: RLD2104
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
In-Jin Jang, M.D.
Seoul National University Hospital
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
July 15, 2021
First Posted
July 23, 2021
Study Start
July 12, 2021
Primary Completion
November 3, 2021
Study Completion
November 3, 2021
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share