A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Peripheral Neuropathy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
Description
This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402. The primary objective of the multiple doses study ...
This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402. The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses. Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses.
Tracking Information
- NCT #
- NCT04453618
- Collaborators
- Not Provided
- Investigators
- Not Provided
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