Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Adult Volunteer
• Interventions: Drug: HIP2101; Drug: RLD2101

• Registration Number: NCT04967014
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

Detailed Description

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

Study Timeline

• Study Start: 2021-05-06
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-18
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	RLD2101	Period I : HIP2104 Period II : RLD2104
Sequence A	HIP2101	Period I : RLD2104 Period II : HIP2104
Sequence B	HIP2101	Period I : HIP2104 Period II : RLD2104
Sequence A	RLD2101	Period I : RLD2104 Period II : HIP2104

Primary Outcome Measures

Name	Time	Method
Duration time with integrated gastric pH>4 / 24hr	0-24hours

Secondary Outcome Measures

Name	Time	Method
Median 24 hr gastric pH	0-24hours
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose	0-24hours

Trial Locations

Locations (1)

Chungbuk University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of