Trials / Completed
CompletedNCT01527734
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
COMPARISON OF THE PHARMACOKINETICS AND SAFETY OF LIQUID (30 µg) AND LYOPHILIZED TETRODOTOXIN (15 µg AND 30 µg) FOLLOWING SINGLE AND TWICE DAILY SUBCUTANEOUS DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS-DETERMINATIONS IN BLOOD AND URINE
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Wex Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tetrodotoxin | 15ug and 30ug once or twice a day for 1 or 2 days. |
| DRUG | placebo | 1ml once or twice a day for 1 or 2 days. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2012-01-01
- First posted
- 2012-02-07
- Last updated
- 2012-02-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01527734. Inclusion in this directory is not an endorsement.