Fed Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg

NCT01183676 | Completed Phase 1

• 1 other identifier: DIVA-0772
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum plasma concentration (micrograms/mL)

  30 days

• AUCL

  Area under the concentration time curve from time zero to the last measurable time point. (micrograms x mL/hour)

  30 days

• AUCI

  Area under the concentration time curve from time zero to infinity (micrograms x mL/hour)

  30 days

Study Arms (2)

Divalproex Sodium

EXPERIMENTAL

DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG - Mylan Pharmaceuticals Inc

Drug: DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG

Depakote Tablets

ACTIVE COMPARATOR

DEPAKOTE® Tablets, 500 MG Abbott Laboratories

Drug: DEPAKOTE® Tablets, 500 MG

Interventions

DEPAKOTE® Tablets, 500 MG DRUG

1 x 500 mg Tablet, under fed conditions

Depakote Tablets

DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG DRUG

1 x 500 mg Tablet, under fed conditions

Divalproex Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years and older.
• Sex: Females not of child bearing potential and males.
• No hormonal contraceptives or hormonal replacement therapies are permitted in this study.
• Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• postmenopausal with spontaneous amenorrhea for at least one (1) year, or spontaneous amenorrhea for less than one (1) year with serum FSH levels \> 40 mIU/ml, or
• bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• total hysterectomy and an absence of bleeding for at least 3 months.
• During the course of the study, from study screen until study exit - including the washout period, all men must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. These instructions should be documented in the informed consent form.
• Weight Restrictions:
• At least 60 kg (132 lbs) for men and
• At least 48 kg (106 lbs) for women
• All subjects will have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19 (see Part II, Administrative Aspects of Bioequivalence Protocols). BMI values should be rounded to the nearest integer (ex. 30.4 rounds down to 30, while 18.5 rounds up to 19)
• All subjects should be judged by the principal or sub-investigator physician listed on the Form FDA 1572 as normal and healthy during a pre-study medical evaluation performed within 21 days of the initial dose of study medication which will include:
• Normal or non-clinically significant physical examination including vital signs,
• Within normal limits or non-clinically significant laboratory evaluation results for the following tests:

You may not qualify if:

• Institutionalized subjects will not be used.
• Social Habits:
• Use of any tobacco-containing products within 1 year of the start of the study.
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits.
• Individual has a history of drug and/or alcohol abuse.
• Medications:
• Use of any prescription or over-the-counter (OTC) medications within fourteen (14) days prior to the initial dose of study medication.
• Use of any hormone replacement therapy within 3 months prior to study medication dosing.
• Use of any medication known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial dose of study medication (see Part II, Administrative Aspects of Bioequivalence Protocols for list).
• Diseases:
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, congenital metabolic disorders or neurologic disease.
• Acute illness at the time of either the pre-study medical evaluation or dosing.
• All laboratory values reflecting hepatic function must be with in 10% of the upper range of normal in order to be considered not clinically significant.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• Mylan Pharmaceuticals Inc - Clinical Trial Results

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: August 18, 2010
• Study Start: July 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 18, 2010

Record last verified: 2010-08

Locations

US (1)