Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets

NCT00685165 | Completed Phase 1 Results

• 1 other identifier: 04090
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.

• Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]

  The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.

Study Arms (2)

Primidone 50 mg Tablets

EXPERIMENTAL

A single dose of primidone 50 mg administered after an overnight fast of at least 10 hours.

Drug: Primidone 50 mg Tablet

Primidone (Mysoline®) 50 mg Tablets

EXPERIMENTAL

A single dose of Mysoline® 50 mg administered after an overnight fast of at least 10 hours.

Drug: Primidone (Mysoline®) 50 mg Tablet

Interventions

Primidone 50 mg Tablet DRUG

50 mg tablet administered after an overnight fast of at least 10 hours.

Primidone 50 mg Tablets

Primidone (Mysoline®) 50 mg Tablet DRUG

50 mg tablet administered after an overnight fast of at least 10 hours.

Also known as: Mysoline®

Primidone (Mysoline®) 50 mg Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Primidone; Tablets

Intervention Hierarchy (Ancestors)

Phenobarbital; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: January 20, 2010
• Results First Posted: January 20, 2010

Record last verified: 2009-11