A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01358344
First received: May 19, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Pantoprazole Drug: SCH 530348 (high percentage) Drug: SCH 530348 (standard percentage) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348 [ Time Frame: Up to 72 hours after SCH 530348 dose on Day 5 ] [ Designated as safety issue: No ]
- Maximal plasma concentration (Cmax) of SCH 530348 [ Time Frame: Up to 72 hours after SCH 530348 dose on Day 5 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Up to 2 weeks after last dose ] [ Designated as safety issue: No ]
| Enrollment: | 173 |
| Study Start Date: | August 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Standard percentage |
Drug: Pantoprazole
40 mg delayed‑release tablet administered orally in the morning of Days 1-7
Drug: SCH 530348 (standard percentage)
2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5
Other Name: Vorapaxar
|
| Experimental: High percentage |
Drug: Pantoprazole
40 mg delayed‑release tablet administered orally in the morning of Days 1-7
Drug: 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
Other Name: Vorapaxar
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01358344 History of Changes |
| Other Study ID Numbers: | P06558 |
| Study First Received: | May 19, 2011 |
| Last Updated: | May 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms |
Pantoprazole Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013