Clinical trial NCT01358344: A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
Official title: A Study to Determine the Bioequivalence of SCH 530348 2.5 mg Tablets Containing a High and Low Percentage of Drug as the Free Base Within the Range Used in the Pivotal Phase 3 Efficacy and Safety Trials. (Protocol No. P06558)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348
timeFrame: Up to 72 hours after SCH 530348 dose on Day 5
measure: Maximal plasma concentration (Cmax) of SCH 530348
timeFrame: Up to 72 hours after SCH 530348 dose on Day 5
Secondary outcomes:
measure: Number of participants experiencing clinical and laboratory adverse events (AEs)
timeFrame: Up to 2 weeks after last dose
Other outcomes:
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Study officials:
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