Comparative Bioavailability Study of Synerx and Verelan PM 300 mg Verapamil HCl ER Capsules Under Fed Conditions
NCT ID: NCT01467687
Last Updated: 2011-11-09
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
58 participants
INTERVENTIONAL
2007-07-31
2007-08-31
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
NONE
Study Groups
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1
300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours.
verapamil controlled release
verapamil 300 mg controlled release capsule as a single dose
2
300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours.
verapamil controlled release
verapamil 300 mg controlled release capsule as a single dose
Interventions
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verapamil controlled release
verapamil 300 mg controlled release capsule as a single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Weighing at least 60 kg for males and 52 kg for females and within the normal range according to accepted normal values of the Body Mass Index Chart (18.00 -28.00 kg/m2).
Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
Exclusion Criteria
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be an acceptable birth control method Postmenopausal women with amenorrhea for at least 2 years will be eligible. Give voluntary written informed consent to participate in the study.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to verapamil, other calcium ion influx inhibitors or any other component of the product formulations; idiosyncratic reaction to acetaminophen; malabsorption within the past year; recurrent headaches or migraines. Presence of a medical condition requiring regular treatment with prescription drugs.
Tests giving reasonable suspicion of a disease that would contraindicate taking an investigational drug or that might affect the interpretation of the results of the study.
Female subjects who are pregnant or lactating. Subjects who tested positive at screening for HIV, HbsAg or HCV. Positive test results for drugs of abuse or alcohol. Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg prior to dosing in each period.
Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each period.
Subjects whose PR interval is \>190 msec at screening and \>200 msec prior to dosing in each period.
Subjects whose QTc interval is \>450 msec at screening and prior to dosing in each period.
Subjects who have used any drugs or substances known to be strong inducers and/or inhibitors of CYP enzymes within 28 days prior to the first dose.
Subjects who have been on a special diet during the 28 days prior to the first dose and throughout the study.
Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.
18 Years
55 Years
ALL
Yes
Sponsors
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Synerx Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Gaetano Morelli, MD
Role: PRINCIPAL_INVESTIGATOR
MDS Pharma
Other Identifiers
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AA32724
Identifier Type: -
Identifier Source: org_study_id