Phase 1
Completed N=22
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Therapeutic Equivalency
Source: ClinicalTrials.gov NCT00685165 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 1,165.92; 1,202.28 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
1,165.92; 1,202.28 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
27,893.57; 27,519.67 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] |
31,162.82; 30,583.92 | — |
Eligibility Criteria
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 gastroesophageal reflux disease (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 (conditions upon screening which might contraindicate or require that caution be used in the administration of primidone)
- heart rate less than 50 beats per minute after a 5 minute rest
- treatment with any other investigational 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.
Data sourced from ClinicalTrials.gov (NCT00685165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.