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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Acute Coronary Syndrome

Treatments

Drug: SCH 530348 (standard percentage)

Drug: SCH 530348 (high percentage)

Drug: Pantoprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358344

P06558

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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