Trials / Completed
CompletedNCT00964262
A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of SR Exenatide (PT302) After Subcutaneous Injection in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Peptron, Inc. · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SR Exenatide (PT302) | 0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection |
| DRUG | Placebo | Plcacebo of each doasage, single subcutanoeus injection |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2009-08-24
- Last updated
- 2013-07-19
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00964262. Inclusion in this directory is not an endorsement.