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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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