Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tegoprazan 50mg

• Registration Number: NCT03863938
• Lead Sponsor: HK inno.N Corporation

Brief Summary

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Detailed Description

Primary Outcome Measure:

1. AUClast and Cmax of tegaprazan

2. Gastric pH

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-03
• Study First Posted: 2019-03-05
• Study Start: 2019-03-27
• Primary Completion: 2019-04-26
• Study Completion: 2019-06-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy adult males aged ≥ 19 years and ≤ 50 years
• Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
• Helicobacter pylori negative

Exclusion Criteria

• Presence or history of clinically significant diseases
• Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
• Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
• Serologic test positive
• Abnormal obstacle to insertion and maintenance of pH meter catheter
• History of drug abuse
• Excessive caffeine intake or persistent alcohol intake
• Not use of a medically acceptable method of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tegoprazan 50mg under fasting condition	Tegoprazan 50mg	Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day
Tegoprazan 50mg after the meal	Tegoprazan 50mg	Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day
Tegoprazan 50mg before the meal	Tegoprazan 50mg	Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day

Primary Outcome Measures

Name	Time	Method
AUClast of tegaprazan	Pre-dose(0 hour) and up to 48 hours in each period	Area under the plasma concentration versus time curve of tegoprazan
Cmax of tegaprazan	Pre-dose(0 hour) and up to 48 hours in each period	Peak Plasma Concentration of tegoprazan
Gastric pH	Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period	Gastric pH

Trial Locations

Locations (1)

Seoul National University Hospital, Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of