Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 56
- Locations
- 5
- Primary Endpoint
- Adverse events
Overview
Brief Summary
The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
Placebo and 140 mg single dose + every 8 hours
Intervention: Placebo (Drug)
Group 1
Placebo and 140 mg single dose + every 8 hours
Intervention: Silymarin (Drug)
Group 2
Placebo and 280 mg single dose
Intervention: Placebo (Drug)
Group 2
Placebo and 280 mg single dose
Intervention: Silymarin (Drug)
Group 3
Placebo and 280mg every 8 hours
Intervention: Placebo (Drug)
Group 3
Placebo and 280mg every 8 hours
Intervention: Silymarin (Drug)
Group 4
Placebo and 280 single dose + every 8 hours
Intervention: Placebo (Drug)
Group 4
Placebo and 280 single dose + every 8 hours
Intervention: Silymarin (Drug)
Group 5
Placebo and 560 mg single dose + every 8 hours
Intervention: Placebo (Drug)
Group 5
Placebo and 560 mg single dose + every 8 hours
Intervention: Silymarin (Drug)
Group 6
Placebo and 560 mg single dose + every 8 hours
Intervention: Placebo (Drug)
Group 6
Placebo and 560 mg single dose + every 8 hours
Intervention: Silymarin (Drug)
Group 7
Placebo and 700 mg single dose + every 8 hours
Intervention: Placebo (Drug)
Group 7
Placebo and 700 mg single dose + every 8 hours
Intervention: Silymarin (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: 10 days
Secondary Outcomes
No secondary outcomes reported