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A Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics of Mianhuahua Flavonoids Tablets After Oral Administration In Healthy Adult Subjects
The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.
Details
| Lead sponsor | Xinjiang Uygur Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 2015-12 |
| Completion | 2016-11 |
Conditions
- Healthy
Interventions
- Mianhuahua Flavonoids Tablets
- Placebo
Primary outcomes
- Safety and tolerability of single and repeated oral administration of Mianhuahua Flavonoids Tablets as measured by the frequency of drug-related clinical adverse events in healthy adults. — Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days
Safety and tolerability will be evaluated through Composite Metrics：adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments.