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C1D06697

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 to 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

Contact recruitment.

Study Visit(s)

Visit Period 1 Period 2
Check In 06-Dec-26 (approximate start time: 13:00) 16-Dec-26 (approximate start time 13:00)
Dosing 07-Dec-26
(approximate start time 08:00)
17-Dec-26
(approximate start time 08:00)
Check Out 08-Dec-26 (approximate start time 21:00) 18-Dec-26 (approximate start time 21:00)
Return #1 (48 hrs.) 9-Dec-26 19-Dec-26
Return # 2 (72 hrs.) 10-Dec-26 20-Dec-26
Return #3 (96 hrs.) 11-Dec-26 21-Dec-26
Return # 4(120 hrs.) 12-Dec-26 22-Dec-26
Return #5 (144 hrs.) 13-Dec-26 23-Dec-26
Return # 6 EOS NA TBD 4 months after Period 2 dosing

Follow-Up Visit(s)

See study visits.

Other Notes

Bring Valid Photo ID.