Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers
A Randomized, Open-label, Multiple-Dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics After Oral Administration of HIP2101 in Healthy Adult Volunteers
1 other identifier
interventional
32
1 country
1
Brief Summary
A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 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 May 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedJuly 19, 2021
July 1, 2021
26 days
July 8, 2021
July 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Duration time with integrated gastric pH>4 / 24hr
0-24hours
Secondary Outcomes (2)
Median 24 hr gastric pH
0-24hours
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
0-24hours
Study Arms (2)
Sequence A
EXPERIMENTALPeriod I : RLD2104 Period II : HIP2104
Sequence B
EXPERIMENTALPeriod I : HIP2104 Period II : 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 18 to 30 kg/m2 and weight 50.0kg 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 (Crohn's disease or Acute/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.
- Aspartate aminotransferase and alanine aminotransferase exceed 2 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 6 months before the first administration or who cannot abstain from consent to post-study visit.
- Heavy smoker (\>10 cigarettes/day).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungbuk University Hospital
Cheongju-si, South Korea
Related Publications (1)
Choi YS, Hwang JG, Kim JW, Min H, Seong CH, Hong SH, Kim NY, Park MK. Pharmacodynamics Between a Dual Delayed-Release Formulation of Low-Dose Esomeprazole and Famotidine in Healthy Korean Subjects. Clin Ther. 2024 Aug;46(8):622-628. doi: 10.1016/j.clinthera.2024.06.013. Epub 2024 Jul 20.
PMID: 39033046DERIVED
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 8, 2021
First Posted
July 19, 2021
Study Start
May 6, 2021
Primary Completion
June 1, 2021
Study Completion
June 18, 2021
Last Updated
July 19, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share