Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed Condition

NCT ID: NCT01056627

Last Updated: 2010-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-03-31

Brief Summary

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 fed conditions.

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 fed conditions with an adequate washout period of 10 days.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Divalproex Sodium

Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Divalproex Sodium

Intervention Type: DRUG

Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited

Depakote Sprinkle

Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA

Group Type: ACTIVE_COMPARATOR

Divalproex Sodium

Intervention Type: DRUG

Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited

Interventions

Divalproex Sodium

Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited

Intervention Type: DRUG

Other Intervention Names

Depakote Sprinkle

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr.Reddy's Laboratories Limited,

Principal Investigators

S Sai Krishna, MBBS

Role: PRINCIPAL_INVESTIGATOR

Bioserve Clinical Research Pvt. Ltd.

Locations

Bioserve Clinical Research Pvt. Ltd.

Hyd, Andhra Pradesh, India

Countries

India

Other Identifiers

637/06

Identifier Type: -

Identifier Source: org_study_id