A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)

Inclusion criteria

• Body Mass Index (BMI) between 18 and 32, inclusive
• Clinical laboratory tests within normal limits
• Free of any clinically significant disease that would interfere with the study evaluations
• Screening 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
• Vital sign measurements within the following ranges: oral body temperature, 35.0°C to 37.5°C; systolic blood pressure, 90 to 140 mmHg; diastolic blood pressure, 45 to 90 mmHg; pulse rate, 40 to 100 beats per minute
• Female participants must be postmenopausal, surgically sterile, abstinent, or using medically accepted method of contraception for 3 months prior to the screening period, during the trial, and for 2 months after stopping the trial. Non-vasectomized men must agree to use acceptable contraception or to abstain from sexual intercourse during the trial and for 3 months after stopping the medication

Exclusion criteria

• Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding
• History of coagulation disorder(s), thrombocytopenia, bleeding tendency, ulcers, or gastrointestinal bleeding
• History of cardiac abnormalities including clinically relevant ECGs, frequent palpitations or syncopal episodes
• Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
• History of any infectious disease within 4 weeks prior to drug administration
• Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
• Positive screen for drugs with a high potential for abuse
• History of alcohol or drug abuse in the past 2 years
• Blood donation in the past 60 days
• Previous treatment with SCH 530348
• Currently participating in another clinical study or has participated in a clinical study within 30 days
• Demonstrated allergic reactions
• Smokes more than 10 cigarettes or equivalent tobacco use per day
• History of malignancy
• Has received any protocol-defined treatment which could interfere with ability to participate in the trial