The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
44
15ug and 30ug once or twice a day for 1 or 2 days.
1ml once or twice a day for 1 or 2 days.
Comprehensive Clinical Research
Tacoma, Washington, United States
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.
Time frame: 26 timepoints over 48 hours
Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX
Safety was assessed through the collection of AE's, concomitant medications, clinical laboratory assessments, neurological assessments and vital signs. Where summary statistics are presented, these will include n, mean, standard deviation, median, minimum, and maximum.
Time frame: signage of the ICF to Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.