Pharmacodynamics, Healthy Male Volunteers
Conditions
Brief summary
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
Detailed 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.
Interventions
DRUGTegoprazan
Tegoprazan QD for 7 days
DRUGRevaprazan
Revaprazan QD for 7 days
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
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
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 |
|---|---|---|
| Gastric pH | up to 7 days | Gastric pH |
| Serum gastrin concentration | up to 9 days | Serum gastrin concentration |
Countries
South Korea
Outcome results
None listed