Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
1 other identifier
interventional
49
1 country
1
Brief Summary
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 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 Apr 2020
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedOctober 25, 2023
October 1, 2023
6 months
February 28, 2020
October 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
0-24hours
Reduced 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)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALInterventions
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
Related Publications (1)
Kim Y, Bae S, Jeon I, Kwon J, Hong SH, Kim NY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Pharmacodynamics of a Fixed-Dose Combination of Esomeprazole and Magnesium Hydroxide Compared to the Enteric-Coated Esomeprazole. Clin Ther. 2024 Nov;46(11):870-876. doi: 10.1016/j.clinthera.2024.08.006. Epub 2024 Sep 16.
PMID: 39289057DERIVED
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
February 28, 2020
First Posted
March 27, 2020
Study Start
April 29, 2020
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share