NCT01581775

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 fasting conditions and to monitor adverse events and ensure the safety of subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

April 4, 2012

Last Update Submit

April 19, 2012

Conditions

Healthy

Keywords

BioequivalenceDivalproex SodiumCrossover

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 SodiumDRUG

Divalproex Sodium ER Tablets, 500 mg

Also known as: Depakote
Depakote ER Tablets, 500 mgDivalproex Sodium ER Tablets, 500 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veeda Clinical Research, India

Ahmedabad, Gujarat, 380 015, India

Location

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

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

January 1, 2011

Study Completion

March 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

IN(1)