An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of CG5503 Immediate-Release Capsule in Healthy Elderly and Young Subjects
Completed
- Conditions
- acute en chronische pijnchronic painpain
- Registration Number
- NL-OMON30712
- Lead Sponsor
- Johnson & Johnson Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
male
female (surgically sterilized or post-menopausal for at least two years or use for this study an acceptable method of birth control)
age 18-45 years
age 65 years and older
BMI is between 20 - 30 kg/m2 with a weight of not less than 50 kg
no smoking or you not smoking more than 10 cigarettes/day
Kidney function: for elderly CLCR > 60 mL/min; for young subjects CLCR at least 80 mL/min
Exclusion Criteria
Important medical disorder, e.g., hepatitis B, cancer or HIV/AIDS.
Participation in another drug study within 60 days before the start of this study.
Blood donation within the 90 days prior to the start of this study or sudden blood loss of similar amount of blood.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>nvt</p><br>
- Secondary Outcome Measures
Name Time Method <p>nvt</p><br>