Study Details

Study Objective

The purpose of this study is to compare and evaluate the pharmacokinetic (the activity of drugs in the body over a period of time, including the processes by which drugs are absorbed, distributed in the body, localized in the tissues, and excreted) profile of standardized botanical extract of saffron and its metabolites (a substance made or used when the body breaks down food, drugs or chemicals, or its own tissue) as well as to monitor the safety and tolerability of standardized botanical extract of saffron.

Study Duration

This is a single-period study. The expected duration of the clinical portion is 3 days from the day of check-in. All subjects will be housed in the clinic from at least 11 hours prior to dosing until at least 24 hours post dose.

Study Schedule

General Screening

N/A

Medical Screening

08-Sep-22

Study Visit(s)

Check-In: 15-Sep, Check-Out: 17-Sep

Follow-Up Visit(s)

N/A

Other Notes

Bring Valid Photo ID.