Trials / Completed
CompletedNCT01336582
Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer
Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Samyang Biopharmaceuticals Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.
Detailed description
Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | taxotere | 70 mg/m2 for age of ≥ 65 |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2012-04-01
- Completion
- 2012-08-01
- First posted
- 2011-04-18
- Last updated
- 2012-12-21
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01336582. Inclusion in this directory is not an endorsement.