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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: SCH 530348 (high percentage)
* Drug: SCH 530348 (standard percentage)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Percentage<br> | Drug: Pantoprazole<br>* 40 mg delayed-release tablet administered orally in the morning of Days 1-7<br>Drug: SCH 530348 (standard percentage)<br>* 2.5 mg tablet containing  23% API as free base (STANDARD) administered orally on the morning of Day 5<br>|
| Experimental: High Percentage<br> | Drug: Pantoprazole<br>* 40 mg delayed-release tablet administered orally in the morning of Days 1-7<br>Drug: SCH 530348 (high percentage)<br>* 2.5 mg tablet containing  46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348 |  | Up to 72 hours after SCH 530348 dose on Day 5 | 
| Maximal plasma concentration (Cmax) of SCH 530348 |  | Up to 72 hours after SCH 530348 dose on Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing clinical and laboratory adverse events (AEs) |  | Up to 2 weeks after last dose |