A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

HK inno.N

Status and phase

Completed

Phase 1

Conditions

Pharmacodynamics

Healthy Male Volunteers

Treatments

Drug: Revaprazan

Drug: Tegoprazan

Study type

Interventional

Funder types

Industry

Identifiers

NCT03378284

CJ_APA_108

Details and patient eligibility

About

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Full description

To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.
To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Enrollment

16 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

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