A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

NCT04703868 | Completed Phase 1

• 1 other identifier: YJ26-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• Integrated gastric acidity

  Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose

  From Day 1 up to Day 28

• AUCt,ss

  Evaluateion PK Rabeprazole after multiple dose

  From Day 1 up to Day 29

Secondary Outcomes (16)

• Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose

  24 hours

• Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose

  From Day 1 up to Day 28

• Mean and median gastric pH after 1st and 7th dose

  From Day 1 up to Day 28

• AUCτ

  From Day 1 up to Day 29

• Cmax

  From Day 1 up to Day 29

Study Arms (2)

YPI-011 10/500mg

EXPERIMENTAL

Part A: 1 tablet administered before the breakfast during 7 days

Drug: Rabeprazole Sodium 10mg

YPI-011 20/500mg

EXPERIMENTAL

Part B: 1 tablet administered before the breakfast during 7 days

Drug: Rabeprazole Sodium 20mg

Interventions

Rabeprazole Sodium 10mg DRUG

Part A: 1 tablet administered before the breakfast during 7 days

Also known as: Reference drug

YPI-011 10/500mg

Rabeprazole Sodium 20mg DRUG

Part B: 1 tablet administered before the breakfast during 7 days

Also known as: Reference drug

YPI-011 20/500mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 19\~55 years in healthy volunteers
• BMI is more than 18.0 kg/m\^2 , no more than 28.0 kg/m\^2
• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

You may not qualify if:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
• Subjects who were judged ineligible by the investigator

Sponsors & Collaborators

• Yungjin Pharm. Co., Ltd.: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Daehak-ro Jongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Seunghwan Lee, M.D., Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: January 7, 2021
• First Posted: January 11, 2021
• Study Start: January 13, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 14, 2021
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

KR (1)