Study Details

Study Purpose

The purpose of this study is to see if the test product (investigational drug) is the same as the reference product (the approved version of the drug) by measuring the how much of each product is present in the blood after the product is consumed. This study will also monitor the safety of these products.

Study Duration

After screening, the expected study duration will be approximately 30 days from the day of check-in of the first period with a minimum of 25 days between treatment periods (washout period).

Screening Visit (Day -30 To Day -1): (about 3 hours-but may vary)

Check-in Visit (Day -1) of Periods 1 and 2: Pre-Dosing Overnight Stay

"Ambulatory Visits (Day 3 & 4 – Period 1 and 2):  Collection of blood sample will be performed at 48 and 72 hours postafter study drug dosing. "

Study Schedule

General Screening

N/A

Medical Screening

Contact recruitment

Study Visit(s)

Contact recruitment

Follow-Up Visit(s)

N/A

Other Notes