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

A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03863938

Enrollment

Registered

2019-03-05

Start date

2019-03-27

Completion date

2019-06-25

Last updated

2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGTegoprazan 50mg

K-CAB

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026