| May 24, 2008 |
| May 24, 2008 |
| May 2004 |
| June 2004 (final data collection date for primary outcome measure) |
| Bioequivalence [ Time Frame: Two Weeks ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
| |
| |
| |
| Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets |
| A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet of Primidone 50mg, Compared to an Equivalent Dose of Mysoline in Healthy Adult Subjects |
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline(primidone tablets) in adult subjects under fasting conditions. |
| |
| Phase I |
| Interventional |
| Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Therapeutic Equivalency |
| Drug: primidone |
- Experimental: One tablet containing 50mg of test product to be administered at hour 0 on Day 1 of each test period
- Active Comparator: One Mysoline tablet containing 50mg reference product to be administered at hour 0 on Day 1 of each test period
|
| |
| |
| Completed |
| 22 |
| June 2004 |
| June 2004 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- male or female
- at least 18 years of age
- weight must be 15% of ideal weight for height and frame
- subjects must be in good health and physical condition as determined by medical history
- subjects must read and sign consent form
Exclusion Criteria:
- history of treatment for alcoholism, substance abuse, or drug abuse within the last 24 months
- history of malignancy, stroke, diabetes, cardiac, renal or liver disease
- history of GERD, malabsorption syndrome, colon cancer, chronic colitis, including Crohn's disease
- history of porphyria, hyperkinesia, respiratory diseases (eg. asthma, emphysema, difficulty breathing, pulmonary obstruction)
- females who pregnant or lactating
- history of hypersensitivity to primidone, barbiturates, and anticonvulsants
- sitting systolic blood pressure below 90mm Hg, or diastolic pressure below 50mm Hg
- heart rate less than 50 beats per minute after a 5 minute rest
- treatment with any other investigation drug during the four weeks prior to initial dosing
- subjects who have donated blood within four weeks prior to the initial dosing
- subjects who smoke or use tobacco products or nicotine products. Three months abstinence is required.
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00685165 |
| Kristin Arnold, Vice President R&D, Mutual Pharmaceutical Company, Inc. |
| 04090 |
| Mutual Pharmaceutical Company, Inc. |
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| Mutual Pharmaceutical Company, Inc. |
| May 2008 |