Clinical TrialID 4830
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
NCT01527734
Healthy
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 4830
- Evidence Id
- 4830
- Core Evidence Id
- 4830
- Source Clinical Trial Id
- 4805
- Herb2 Clinical Trial Id
- HBCT004805
- Nct Id
- NCT01527734
- Title
- Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Healthy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
- Intervention
- DRUG: Tetrodotoxin|DRUG: placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Quadruple
- Intervention Purpose
- Screening
- Gender
- All
- Age
- Adult
- Enrollment
- 44
- Outcome Measure
- Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX, PK timepoints occurred at 0,0.33,0.67,1, 1.5,2,4,6,8,10,12,14 and 24 hours after first dose on Days 1 \& 2. Liquid and Lyophilized formulations will be assessed using ANOVA of the T-R ratio based on log-transformed AUC and Cmax values., 26 timepoints over 48 hours
- Sponsor Collaborator
- Wex Pharmaceuticals Inc.
- Funded By
- INDUSTRY
- Location
- Comprehensive Clinical Research, Tacoma, Washington, 98418, United States
- Other Id
- TTX-CINP-201PK
- Start Date
- 2011-12
- Primary Completion Date
- 2012-01
- Completion Date
- First Posted
- 2012-02-07
- Results First Posted
- Last Update Posted
- 2012-02-08
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01527734
- Title Cn
- Title En
- Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
- Bilingual Status
- semi_complete