A Open-label, Single-dose, Phase 1 Study to Compare and Evaluate the Safety and Pharmacokinetics According to the Dose of Camostat Mesylate in Healthy Volunteers

DW_DWJ1248101

Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers

2021-03-12

2021-03-16

2021-06-28

Completed

Early phase I

61

Inclusion Criteria: * Healthy adults aged ≥ 19 and ≤ 55 years at screening * Subjects with body weight of ≥ 55.0 kg and ≤ 90.0 kg, and a body mass index (BMI) of ≥ 18.0 and ≤ 29.9 * Subjects who have no congenital or chronic disease and have no pathological symptoms or findings as a result of an internal examination Exclusion Criteria: * Subjects with current or prior history of a clinically significant hepatic, renal, nervous, respiratory, gastrointestinal, endocrine, hematologic and oncologic, urogenital, cardiovascular, musculoskeletal or psychiatric disorder * Subjects with symptoms of acute disease within 28 days prior to the scheduled first administration date of IP * Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia surgery) that may affect the absorption of drugs.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part1. Parallel, Part2. Crossover', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}

2022-12-05