Type of Study: Single Ascending Doses (SAD) Study
Objectives:
- To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral
administration of SAD ranging from 200 mg up to a dose currently estimated at 1,000 mg,
in healthy subjects.
- To evaluate the safety and tolerability of JOTROL
- To evaluate the effect of food on the PK profile of JOTROL. Study Design: Phase I,
randomized, open-label, sequential SAD study with a food effect evaluation. Blood plasma
and urine samples will be assessed for resveratrol and key metabolite content.
Type of Control: No control Test Product: JOTROL (resveratrol) 100 mg resveratrol in 1000 mg
softgel capsule for oral administration Dosage Regimen: Planned dose levels of resveratrol:
200 mg, 500 mg, and 1,000 mg. Following completion of each dose level, PK, safety, and
tolerability data will be evaluated; dose levels may be adjusted.
Route of Administration: Oral gelcaps with water Number of Subjects: 24 subjects will be
included in Part 1; only 16 subjects, who completed Part 1, will be included in Part 2.
Subjects: Healthy, non-smoker, adult males or females, ≥ 18 and ≤ 75 years of age Study
Duration: Participation of each subject in this study should last approximately 1 to 1.5
months (for subjects participating in study Part 1 only) and 1.5 to 2 months (for subjects
participating in both study parts).