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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tegoprazan 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03863938

CJ_APA_112

Details and patient eligibility

About

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

Full description

Primary Outcome Measure:

1. AUClast and Cmax of tegaprazan
2. Gastric pH

Enrollment: 12 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Tegoprazan 50mg under fasting condition

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan 50mg

Tegoprazan 50mg before the meal

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan 50mg

Tegoprazan 50mg after the meal

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan 50mg