Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132040
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : May 27, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

Brief Summary:
The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in healthy, adult, human subjects under fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Primidone Phase 1

Detailed Description:
An open label, balanced. randomized, two-treatment, two-period, two-sequence, single dose,crossover, bioequivalence study of Primidone 50 mg tablets of Dr.Reddy's Laboratories Limited, Generics, India comparing with that of Mysoline (containing Primidone 50 mg) tablets of Yamanouchi Pharma Technologies Inc, Norman, OK in healthy, adult, human subjects under fasting conditions with a washout period of 14 days.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Balanced. Randomized, Two-treatment, Two-period, Two-sequence, Single Dose,Crossover, Bioequivalence Study of Primidone 50 mg Tablets of Comparing With That of Mysoline® 50 mg Tablets Under Fasting Conditions.
Study Start Date : August 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Primidone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Primidone
Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories
Drug: Primidone
Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited
Other Name: Mysoline
Active Comparator: Mysoline
Mysoline Tablets of Yamanouchi Pharma Technologies Inc,
Drug: Primidone
Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited
Other Name: Mysoline

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects must fulfill all of the following criteria to be considered for inclusion into this study:

  1. Subjects who will provide written informed consent.
  2. Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg.
  3. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
  4. Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
  5. Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.
  6. Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.

Exclusion Criteria:

The subjects will be excluded based on the following criteria during screening and during the study

  1. Subjects incapable of understanding the informed consent.
  2. Subjects who have:

    1. Systolic blood pressure less than 90 mm ofHg or more than 140 mm of Hg
    2. Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.
    3. Pulse rate below 50/min or above 100/min.
  3. History of hypersensitivity or idiosyncratic reaction to study drug or any other related drugs.
  4. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  5. Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
  6. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and during sampling period.
  7. Subjects who have taken over the counter or prescribed medications and enzyme modifying or any systemic medication for during the last 7 and 30 days respectively before dosing.
  8. Subjects who have participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
  9. Subjects with clinically significant abnormalities (such as Laboratory Findings, ECG, X-Ray,Drugs of abuse, Alcohol etc.,) and/or with significant diseases (such as HIV, Hey, Syphilis,Hepatitis B etc.,).
  10. Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132040

Bioserve Clinical Research Pvt. Ltd,
HYD, Andhra Pradesh, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Mohanlal shiva prasad sayana Bioserve Clinical Research Pvt. Ltd., Hyderabad, A.P.

Responsible Party: Mr. Indu Bhushan / Sr. Director - R&D, Dr. Reddy's Laboratories Limited Identifier: NCT01132040     History of Changes
Other Study ID Numbers: P-620/06
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Dr. Reddy's Laboratories Limited:

Additional relevant MeSH terms: