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Mississauga, Ontario Study Details

C1D06693

Study Type Demographic Gender Age Location Compensation
Healthy Healthy; non-smokers for at least the past 1 year; other criteria will be assessed. Males & Females 18 - 55 years Mississauga, ON Up to $6,120
Study Details

Study Purpose

The purpose of this study is to compare the amount of active drug in your blood after a 26 mg once daily dose of the test product (T) given in the morning, with a 26 mg twice-daily dose (13 mg in the morning and 13 mg in the evening) of the reference product.

Study Duration

Two periods, spaced 10 days apart, with confinement 14 hrs. prior to dosing from check-in, plus 36 hrs. after you take the study drug; 5 return visits per period (approx. 1-2 hrs duration). One end of study visit 4 months after the last dose of period 2.

Study Schedule

General Screening

NA

Medical Screening

July 20, 24, 28, 30

Study Visit(s)

 COHORT 1
Visit Period 1 Period 2
Check In 13-Aug-26 (13:00 onwards) 23-Aug-26 (13:00 onwards)
Dosing 14-Aug-26 (08:00 onwards) 24-Aug-26 (08:00 onwards)
Check Out 15-Aug-26 (21:00 onwards) 25-Aug-26 (21:00 onwards)
Return #1 (48 hrs.) 16-Aug-26 26-Aug-26
Return #2 (72 hrs.) 17-Aug-26 27-Aug-26
Return #3 (96 hrs.) 18-Aug-26 28-Aug-26
Return #4 (120 hrs.) 19-Aug-26 29-Aug-26
Return #5 (144 hrs.) 20-Aug-26 30-Aug-26
Return #6 EOS NA TBD 4 mths. after Period 2 dosing


COHORT 2
Visit Period 1 Period 2
Check In 17-Aug-26 (13:00 onwards) 27-Aug-26 (13:00 onwards)
Dosing 18-Aug-26 (08:00 onwards) 28-Aug-26 (08:00 onwards)
Check Out 19-Aug-26 (21:00 onwards) 29-Aug-26 (21:00 onwards)
Return #1 (48 hrs.) 20-Aug-26 30-Aug-26
Return #2 (72 hrs.) 21-Aug-26 31-Aug-26
Return #3 (96 hrs.) 22-Aug-26 1-Sep-26
Return #4 (120 hrs.) 23-Aug-26 2-Sep-26
Return #5 (144 hrs.) 24-Aug-26 3-Sep-26
Return #6 EOS NA TBD 4 mths. after Period 2 dosing

Follow-Up Visit(s)

See study visits.

Other Notes

Bring Valid Photo ID.
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