Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01055938
First received: January 25, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Divalproex Sodium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Balanced, Randomized, Two-treatment, Single-dose, Crossover, Bioequivalence Study of Divalproex Sodium Coated Particles in Capsules, 125 mg With Depakote® Sprinkle 125 mg in Healthy Human Subjects Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence study of Dr.Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: December 2006
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Divalproex Sodium
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Drug: Divalproex Sodium
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other Name: Depakote Sprinkle
Active Comparator: Depakote Sprinkle
Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA
Drug: Divalproex Sodium
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other Name: Depakote Sprinkle

Detailed Description:

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions with an adequate washout period of 10 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 of Hg 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 Investigational drug products 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. Subj eets 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, HCV, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055938

Locations
India
Bioserve Clinical Research Pvt. Ltd.
Hyd, Andhra Pradesh, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: S Sai Krishna, MBBS Bioserve Clinical Research Pvt. Ltd.
  More Information

No publications provided

Responsible Party: Senior Director, R&D, Dr.Reddy's Laboratories Limited,
ClinicalTrials.gov Identifier: NCT01055938     History of Changes
Other Study ID Numbers: P-636/06
Study First Received: January 25, 2010
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014