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St. Petersburg, Florida Study Details

Study Reference No. - C1C04577

Demographic Gender Age Location Compensation
- Males & Females 18-50 years old both inclusive Saint Petersburg FL Up to $2450
Study Details

Study Purpose

Study Objective: The purpose of this study is to see if the test products (investigational drug that are new and not yet approved by the U.S. Food and Drug Administration [FDA]) are the same as the reference product (the approved version of the drug) by measuring the concentration of each product in the blood. This study will also monitor the safety of the study subjects.

Study Duration

After screening and considering the minimum washout period of 14 days, the expected study duration will be approximately 33 days from the day of check-in of the first period

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

Period I, II and III: At least 18 hours prior to dosing of IP (Investigational Product) until at least 48 hours post dose of IP in each period.

Ambulatory visits: Subjects will report to the clinical facility at 72.0 hours post-dose (of IP) for compliance assessment, AE assessment and collection of ambulatory blood samples in each period.
Study Schedule

General Screening

NA

Medical Screening

Contact recruitment

Study Visit(s)

Contact recruitment

Follow-Up Visit(s)

NA

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