An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of CG5503 Immediate-Release Capsule in Healthy Elderly and Young Subjects

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of CG5503 Immediate-Release Capsule in Healthy Elderly and Young Subjects - CG5503 IR pharmocokinetics in young and elderly

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30712

Enrollment

Registered

2006-08-23

Start date

2006-09-20

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute en chronische pijn chronic pain pain

Interventions

nvt

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
nvt	—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)