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

NCT ID: NCT03863938

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2019-06-25

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tegoprazan 50mg under fasting condition

Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day

Group Type: EXPERIMENTAL

Tegoprazan 50mg

Intervention Type: DRUG

K-CAB

Tegoprazan 50mg before the meal

Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day

Group Type: EXPERIMENTAL

Tegoprazan 50mg

Intervention Type: DRUG

K-CAB

Tegoprazan 50mg after the meal

Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day

Group Type: EXPERIMENTAL

Tegoprazan 50mg

Intervention Type: DRUG

K-CAB

Interventions

Tegoprazan 50mg

K-CAB

Intervention Type: DRUG

Other Intervention Names

Tegoprazan 50mg tablet

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Jin Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Dept. of Clinical Pharmacology

Locations

Seoul National University Hospital, Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_APA_112

Identifier Type: -

Identifier Source: org_study_id