Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
- Registration Number
- NCT01809301
- Lead Sponsor
- Cortria Corporation
- Brief Summary
The objective of this study is to compare the absorption of a niacin metabolite (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used to adjust the top dose of a planned TRIA-622 efficacy study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TRIA-662 TRIA-662 Single dose of two TRIA-662, 500 mg Immediate-Release Tablets following dinner Niaspan Niaspan Single dose of one NIASPAN® 1000 mg Extended-Release Tablet following dinner
- Primary Outcome Measures
Name Time Method ANOVA and 90% Confidence Intervals on ln-transformed, baseline corrected molar urine recovery data of niacin metabolites. 96 hours of urine collection
- Secondary Outcome Measures
Name Time Method Peak plasma concentration (Cmax)of each niacin metabolite Pre-dose and at 1, 2, 3, 5, 6, 12, 16, 20, 24 and 30 hours after dosing in each study period. Plasma area under the curve to the last measureable timepoint, AUCt Pre-dose and at 1, 2, 3, 5, 6, 12, 16, 20, 24 and 30 hours after dosing in each study period.
Trial Locations
- Locations (1)
Bio Pharma Services Inc. (BPSI)
🇨🇦Toronto, Ontario, Canada