Healthy
Conditions
Brief summary
To evaluate the safety and the pharmacokinetics of the JP-1366 20 mg tablet and capsule oral administration in healthy adult volunteers.
Interventions
T : JP-1366 20mg tablet
DRUGJP-1366 20mg capsule
R : JP-1366 20mg capsule
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects ≥ 19 years of age 2. Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
Exclusion criteria
1. Subjects with clinically significant diseases or a medical history related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infections diseases, kidney and urinary system, psychiatric and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin, and ophthalmological system 2. Subjects who have a history of gastrointestinal surgery (except simple appendectomy or herniotomy) or have gastrointestinal disorders that may affect the absorption of the drug 3. Subjects who received inducers or inhibitors of drug metabolizing enzymes 4. Subjects who have hypersensitivity to this drug, ingredients of this drug, or benzimidazoles, or have a medical history thereof 5. Patients receiving drugs containing atazanavir, nelfinavir, or rilpivirine 6. Subjects who are judged ineligible to participate in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt of Zastaprazan(JP-1366 20mg) | Pre-dose(0 hour) and up to 34 hours in each period |
| Cmax of Zastaprazan(JP-1366 20mg) | Pre-dose(0 hour) and up to 34 hours in each period |
Countries
South Korea
Outcome results
None listed