Saroglitazar magnesium food-effect study
10 evidence topics · 1 source
Objective
Food-effect comparison
Location and study date
No evidence found.
Study design
Randomized crossover design
Eligibility criteria
Healthy-volunteer population
Treatment
Single-dose tablet strength
Study outcomes
Rationale for using pharmacokinetic parameters as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
Pharmacokinetic analysis
Results
Participant disposition
Study completion
| Disposition | Participants |
|---|---|
| Completed | “50” |
Baseline characteristics
No evidence found.
Efficacy results
Health-related quality of life and patient-reported outcomes
Not applicable.
Safety results
Reported adverse-event severity
Study limitations
Summary
The study evaluated a single 4 mg tablet in healthy volunteers under fed and fasting conditions. Fifty of 54 enrolled participants completed and were analyzed. These results do not directly establish food effects after repeated 1 mg dosing in PBC.