Trials / Completed
CompletedNCT02241200
A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESP® (Amgen)
A Randomized, 2 Part, 4-treatment, 2-way Cross-over Study in Healthy Volunteers to Compare the Pharmacokinetic and Pharmacodynamic Profiles of 1ug/kg of DA-3880 and EU Sourced ARANESP® (Amgen) After Single Intravenous or Subcutaneous Administration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Dong-A ST Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of the study is to determine whether the test product and the reference product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a single intravenous dose and as a single subcutaneous dose of each of the formulations. The study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DA3880 | |
| DRUG | Aranesp |
Timeline
- Start date
- 2014-08-18
- Primary completion
- 2014-11-29
- Completion
- 2014-11-29
- First posted
- 2014-09-16
- Last updated
- 2021-06-15
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02241200. Inclusion in this directory is not an endorsement.