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Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
This study has been completed.
Study NCT00685165   Information provided by Mutual Pharmaceutical Company, Inc.
First Received: May 24, 2008   No Changes Posted

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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.
 
 
Mutual Pharmaceutical Company, Inc.
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP