A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01202734

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

10

Starts

2010-09-01

Expected to finish

2010-11-01

Last updated by the study team

2014-05-16

Who can join

Age: 20 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive
• Body weight of not less than 50 kg
• Supine (lying down) blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic

You may not qualify if…

• History of or current medical illness judged by the investigator to be clinically significant
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of study drug
• History of drug or alcohol abuse within the past 5 years
• History of smoking or use of nicotine containing substances within the previous 2 months

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

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