Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions

NCT01581788 | Completed Phase 1 DMC

• 1 other identifier: 10-vin-123
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure the safety of subjects.

Conditions

Healthy

Keywords

Bioequivalence; Divalproex Sodium; Crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  Pre-dose 1 hour, 1.50, 3, 4.50, 6, 7.50, 9, 10.50, 12, 13.50, 15, 16.50, 18, 19.50, 21, 22.50, 24, 25.50, 27, 32, 36, 48, 60, 72, 96 hours post-dose

Study Arms (2)

Divalproex Sodium ER Tablets, 500 mg

EXPERIMENTAL

Divalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited

Drug: Divalproex Sodium

Depakote ER Tablets, 500 mg

ACTIVE COMPARATOR

Depakote ER Tablets, 500 mg of Abbott Laboratories

Drug: Divalproex Sodium

Interventions

Divalproex Sodium DRUG

Divalproex Sodium ER Tablets, 500 mg

Also known as: Depakote

Depakote ER Tablets, 500 mg; Divalproex Sodium ER Tablets, 500 mg

Eligibility Criteria

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

You may qualify if:

• The subjects were selected for study participation, if they met the following criteria:
• Subjects aged between 18 and 45 years (both inclusive).
• Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
• Subjects having normal 12-lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Subjects having negative alcohol breath test.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.

You may not qualify if:

• The subjects were excluded from the study, if they met any of the following criteria:
• Hypersensitivity to Divalproex or related class of drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
• History or presence of significant alcoholism or drug abuse.
• History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
• History or presence of asthma, urticaria or other significant allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• History or presence of cancer.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
• Major illness during 3 months before screening.
• Participation in a drug research study within past 3 months.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Veeda Clinical Research, India

Ahmedabad, Gujarat, 380 015, 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

• Dr. Gunjan Shah, MBBS

  Veeda Clinical Research, India

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 20, 2012
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

IN (1)