Study Reference No. - C1C04946
| Study Type | Demographic | Gender | Age | Compensation | Location |
|---|---|---|---|---|---|
| Injectable | BMI: 19 to 30, both inclusive | Males and non-lactating and/non-pregnant females | 18-55 years old both inclusive | Up to $ 2670 | Saint Petersburg FL |
Study Details |
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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 how much of each product is present in the blood and how your immune system responds to the drug after the product is administered. This study will also monitor the safety of these products. |
Study Duration |
This is a 2-period study. The expected study duration will be approximately 51 days from the day of check-in of the first period to the last study procedure; 34 days between treatment periods (washout period); 5 ambulatory visits per period plus 1 added ambulatory 1 day prior to check-in for Period 2 only; confinement of 14-hours prior to dosing and 48-hours post-dose in each period. |
Study Schedule |
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General Screening |
NA |
Medical Screening |
Contact recruitment |
Study Visit(s) |
Contact recruitment |
Follow-Up Visit(s) |
NA |