CompletedPhase 1

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

United States20 participantsStarted 2007-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: 18 years and older.
. Sex: Females not of child bearing potential and males.
. Weight Restrictions:
. 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:
. Negative Hepatitis B and Hepatitis C tests,
. Negative HIV test,

Exclusion criteria

. Institutionalized subjects will not be used.
. Social Habits:
. Use of any tobacco-containing products within 1 year of the start of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax

Timeframe: 30 days

AUCL

Timeframe: 30 days

AUCI

Timeframe: 30 days

Trial details

NCT IDNCT01183676

SponsorMylan Pharmaceuticals Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: 18 years and older.
. Sex: Females not of child bearing potential and males.
. Weight Restrictions:
. 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:
. Negative Hepatitis B and Hepatitis C tests,
. Negative HIV test,

Exclusion criteria

. Institutionalized subjects will not be used.
. Social Habits:
. Use of any tobacco-containing products within 1 year of the start of the study.