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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pantoprazole; Vorapaxar

Criteria

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