Relative Bioavailability Study and Food Effect Study of TT-00420 Capsule and Tablet Formulations in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Both males and females
Description
Subjects will be randomized to one of three treatment sequences. Each sequence will contain up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period, three treatment periods, and a follow-up visit. Subjects will be administered a single dose of TT-00420 on Day 1 of ...
Subjects will be randomized to one of three treatment sequences. Each sequence will contain up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period, three treatment periods, and a follow-up visit. Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition, TT-00420 tablet under fasting condition, or capsule under fasting condition and crossed over after at least a 14-day washout period.
Tracking Information
- NCT #
- NCT04705922
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mohamed Al-Ibrahim Pharmaron CPC