Clinical trial NCT04975711: Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers
Official title: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: AUCtau
timeFrame: 0-24hours
measure: changed rate from baseline in 24h integrated gastric pH
timeFrame: 0-24hours
Secondary outcomes:
measure: Cmax
timeFrame: 0-24hours
measure: Tmax
timeFrame: 0-24hours
measure: t1/2
timeFrame: 0-24hours
measure: CL/F
timeFrame: 0-24hours
measure: Vd/F
timeFrame: 0-24hours
measure: AUClast
timeFrame: 0-24hours
measure: Cmin,ss
timeFrame: 0-24hours
measure: Cmax,ss
timeFrame: 0-24hours
measure: t1/2,ss
timeFrame: 0-24hours
measure: CLss/F
timeFrame: 0-24hours
measure: Vd,ss/F
timeFrame: 0-24hours
measure: changed rate from baseline in 24h integrated gastric pH
timeFrame: 0-24hours
measure: Duration time with integrated gastric pH>4 / 24hr
timeFrame: 0-24hours
measure: Median 24 hr gastric pH
timeFrame: 0-24hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: