A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
Phase 1
Completed
- Conditions
- Acute Coronary Syndrome
- Interventions
- Registration Number
- NCT01358344
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard Percentage Pantoprazole - Standard Percentage SCH 530348 (standard percentage) - High Percentage SCH 530348 (high percentage) - High Percentage Pantoprazole -
- Primary Outcome Measures
Name Time Method Maximal plasma concentration (Cmax) of SCH 530348 Up to 72 hours after SCH 530348 dose on Day 5 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
- Secondary Outcome Measures
Name Time Method Number of participants experiencing clinical and laboratory adverse events (AEs) Up to 2 weeks after last dose