A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers
The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of Methylphenidate HCl in healthy Japanese adult male volunteers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-label, Single-Ascending-Dose Study to Investigate the Pharmacokinetics and Safety of CONCERTA in Healthy Japanese Adult Male Subjects|
- Plasma concentrations of total methylphenidate HCl and its major metabolite, a-phenyl-piperidine-acetic acid (PPAA) [ Time Frame: At protocol-specified times on Day 1 through Day 3 in Treatment Periods 1, 2, and 3 ] [ Designated as safety issue: No ]
- The number and type of treatment-emergent adverse events [ Time Frame: Day 1 of Period 1 through Day 3 of Period 3 (approximately 23 days) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||November 2010|
Methylphenidate HCl Period 1: One tablet oral 36 mg once daily single-dose on Day 1 Period 2: Three tablets oral 18 mg once daily single-dose on Day 1 Period 3: Two tablets oral 36 mg once daily single-dose on Day 1. (Each treatment period will be separated by 3-7 days)
Drug: Methylphenidate HCl
Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1
This is an open-label (name of assigned treatment is known), single-center study of the pharmacokinetics (blood levels) and safety of 3 single doses of methylphenidate HCl administered orally (by mouth) to healthy Japanese adult male volunteers. Methylphenidate HCl is a drug that is currently approved for the treatment of adults with attention-deficit/hyperactivity disorder (ADHD) in regions outside Japan, including the United States where this study will be conducted. Volunteers will participate in the study for a maximum of 42 days. Blood samples will be collected from volunteers during the study to determine the concentration of the methylphenidate HCl in the blood after dosing. Safety will be monitored throughout the study by evaluating adverse events reported, changes in clinical laboratory test results, vital signs measurements, physical examination results, and other protocol-specified safety assessments. All volunteers will receive a single oral dose of methylphenidate HCl with 240 mL (1 cup) of noncarbonated water after at least a 10-hour fast (without eating food) during 3 treatment periods as follows: Period 1, one 36-mg tablet; Period 2, three 18-mg tablets; and Period 3, two 36-mg tablets. Treatment periods will be separated by 3 to 7 days. Volunteers will continue fasting until at least 4 hours after dosing.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|