Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
Summary
The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following by a single, oral 300 mg (1 x 300 mg) dose administration sprinkled on one tablespoon of applesauce under fasting conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Verapamil Hydrochloride Extended-Release Capsules, 300 mg, Verelan® PM Extended-Release Capsules, 300 mg
Location
PRACS Institute, Ltd.
Fargo
North Dakota
United States
58104
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00649805
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Contact Lenses, Extended-wear
Hydrophilic contact lenses worn for an extended period or permanently.
Breech Presentation
A malpresentation of the FETUS at near term or during OBSTETRIC LABOR with the fetal cephalic pole in the fundus of the UTERUS. There are three types of breech: the complete breech with flexed hips and knees; the incomplete breech with one or both hips partially or fully extended; the frank breech with flexed hips and extended knees.
Msh Release-inhibiting Hormone
A hypothalamic tripeptide, enzymatic degradation product of OXYTOCIN, that inhibits the release of MELANOCYTE-STIMULATING HORMONES.
Thromboxane B2
A stable, physiologically active compound formed in vivo from the prostaglandin endoperoxides. It is important in the platelet-release reaction (release of ADP and serotonin).
Biohazard Release
Uncontrolled release of biological material from its containment. This either threatens to, or does, cause exposure to a biological hazard. Such an incident may occur accidentally or deliberately.
Clinical Trials
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