SARO.24.003
6 evidence topics · 1 source
Objective
Pharmacokinetic objective
Location and study date
No evidence found.
Study design
Open-label phase 1 design
Eligibility criteria
Moderate hepatic impairment eligibility
| Criterion | Quoted value |
|---|---|
| Child-Pugh Turcotte score | “7 to 9” |
Treatment
Alternate-day regimen
| Regimen characteristic | Quoted value |
|---|---|
| Saroglitazar magnesium tablet strength | “1 mg” |
| Dosing schedule | “alternate days” |
| Duration | “29 days” |
Study outcomes
Rationale for using pharmacokinetic parameters as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Planned enrollment
| Population | Estimated participants |
|---|---|
| Single-arm pharmacokinetic study | “6” |
Description of analysis sets
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
Not applicable.
Safety results
No evidence found.
Study limitations
Summary
The planned study contains six participants and no randomized control group. It evaluates alternate-day administration in moderate hepatic impairment. The record provides no observed pharmacokinetic or safety results.