A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
NCT ID: NCT01358344
Last Updated: 2015-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
173 participants
INTERVENTIONAL
2010-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Standard Percentage
Pantoprazole
40 mg delayed-release tablet administered orally in the morning of Days 1-7
SCH 530348 (standard percentage)
2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5
High Percentage
Pantoprazole
40 mg delayed-release tablet administered orally in the morning of Days 1-7
SCH 530348 (high percentage)
2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5
Interventions
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Pantoprazole
40 mg delayed-release tablet administered orally in the morning of Days 1-7
SCH 530348 (high percentage)
2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5
SCH 530348 (standard percentage)
2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P06558
Identifier Type: -
Identifier Source: org_study_id
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