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Phase 1 PK/Safety Study of SA001 in Healthy Males
NCT05303961Phase 1Completed
- Sponsor
- Samjin Pharmaceutical Co., Ltd.
- Start
- Jun 2016
- Primary completion
- Nov 2016
- Modality
- Prodrugs/Conditional Activator Small Molecules
01
Overview
Phase 1, randomised, double-blind trial of rebamipide mofetil in dry eye syndrome (DED) and Sjogren's syndrome (3 arms), sponsored by Samjin Pharmaceutical Co., Ltd. Primary endpoints: Area Under the plasma concentration versus time Curve from the first observed to last at Day 15, Area Under the plasma concentration versus time Curve extrapolated to infinity at Day 15 and 12 more. Started Jun 2016; status: completed.
02
Drugs
rebamipide mofetil
03
Conditions
dry eye syndrome (DED)Sjogren's syndrome
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