94
Participants
Start Date
March 27, 2018
Primary Completion Date
June 20, 2018
Study Completion Date
June 20, 2018
Placebo
Potential subjects will be screened to determine their eligibility for the study within 28 days of the first dose in the Qualification Phase (i.e., Days -28 to -2). Eligible subjects will be admitted to the clinical site on Day -1 of the Qualification Phase (Part 1) and randomized on Day 1 to receive placebo and MPH (60 mg) in 1 of 2 sequences with a 48-hour washout between dose administrations (i.e., dose administration on Days 1 and 3).
Methylphenidate 60 mg
Potential subjects will be screened to determine their eligibility for the study within 28 days of the first dose in the Qualification Phase (i.e., Days -28 to -2). Eligible subjects will be admitted to the clinical site on Day -1 of the Qualification Phase (Part 1) and randomized on Day 1 to receive placebo and MPH (60 mg) in 1 of 2 sequences with a 48-hour washout between dose administrations (i.e., dose administration on Days 1 and 3).
Treatment Phase Sequence 4213
Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
Treatment Phase Sequence 2134
Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
Treatment Phase Sequence 1342
Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
Treatment Phase Sequence 3421
Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
Vince & Associates Clinical Research, Inc., Overland Park
Lead Sponsor
Avekshan LLC
INDUSTRY