Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: HIP1802; Drug: HGP1705

• Registration Number: NCT04324905
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Detailed Description

A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Study Start: 2020-04-29
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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
Sequence 1	HIP1802	-
Sequence 1	HGP1705	-
Sequence 2	HIP1802	-
Sequence 2	HGP1705	-

Primary Outcome Measures

Name	Time	Method
AUClast	0-24hours
Reduced rate from baseline in 24h integrated gastric pH	0-24hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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