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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Divalproex Sodium

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyd, Andhra Pradesh, India, 500 037
      • Bioserve Clinical Research Pvt. Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Depakote Sprinkle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence study of Dr.Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg	4 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (ACTUAL): January 1, 2007
• Study Completion (ACTUAL): March 1, 2007

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (ESTIMATE): January 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 25, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: P-636/06