Overview

Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:

- Body mass index [range is 18.5 to 29.9 kg/m2]

- In good health, determined by no clinically significant findings from medical history,
physical examination, 12-lead ECG, and vital signs

Exclusion Criteria:

- Significant history or clinical manifestation of any significant metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder (as determined by the
investigator)

- History of significant hypersensitivity, intolerance, or allergy to any drug compound,
food, or other substance, unless approved by the investigator

- History of stomach or intestinal surgery or resection that would potentially alter
absorption and/or excretion of orally administered drugs (except that appendectomy,
hernia repair, and/or cholecystectomy will be allowed)

- History or presence of an abnormal ECG, which, in the investigator's opinion, is
clinically significant