Gastroesophageal Reflux Disease (GERD)
Conditions
Brief summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.
Interventions
DRUGAD-120A
Administered before the breakfast during 7 days, Oral, Tablet
DRUGAD-120
Administered before the breakfast during 7 days, Oral, Tablet
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit * The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit * Negative result from Serum Helicobacter pylori antibody at the time of screening visit
Exclusion criteria
* Patients with trouble performing pH monitor catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss) | AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days) | AUCτ,ss after 7days repeated administration of Omeprazole |
| The time of peak concentration after single dose | Tmax: from pre-dose to 24 hours of 1st administration | Tmax after 1days administration of Omeprazole |
| Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring | 24 hours before 1st administration to 24 hours after repeated administration (7days) | Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose |
Countries
South Korea
Contacts
Primary ContactHanna Yang
Backup ContactSeung Hwan Lee, M.D., Ph.D.
Outcome results
None listed