Status:
COMPLETED
Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2021
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04782505
Start Date
March 12 2021
End Date
June 28 2021
Last Update
December 5 2022
Active Locations (1)
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1
Chungnam National University Hospital
Daejeon, South Korea, 35015