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

NCT01055938 | Completed Phase 1

• 1 other identifier: P-636/06
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study of Dr.Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg

  4 months

Study Arms (2)

Divalproex Sodium

EXPERIMENTAL

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

Drug: Divalproex Sodium

Depakote Sprinkle

ACTIVE COMPARATOR

Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA

Drug: Divalproex Sodium

Interventions

Divalproex Sodium DRUG

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

Also known as: Depakote Sprinkle

Depakote Sprinkle; Divalproex Sodium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• The subjects will be excluded based on the following criteria during screening and during the study
• Subjects incapable of understanding the informed consent.
• Subjects who have:
• Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
• 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.
• Pulse rate below 50/min or above 100/min.
• History of hypersensitivity or idiosyncratic reaction to Investigational drug products or any other related drugs.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
• Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
• 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.
• 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.
• 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.
• 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.,).
• Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Pvt. Ltd.

Hyd, Andhra Pradesh, 500 037, India

Location

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• S Sai Krishna, MBBS

  Bioserve Clinical Research Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: December 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

IN (1)