HealthyPhase 1NCT01132170
Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions
A Phase 1 study testing Divalproex Sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Divalproex Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2006to Nov 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- 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.
Who cannot join
- 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 and more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg and 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 and above 100/min.
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- History of hypersensitivity or idiosyncratic reaction to Divalproex sodium 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.
- Subjects 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Bioserve Clinical Research Pvt. Ltd.,
Hyderabad, Andhra Pradesh, 500 037
About this study
Official title: An Open Label, Balanced, Randomized, 2-treatment, 2-period, 2-sequence, Single Dose, Crossover, Bioequivalence Study of Divalproex Sodium DR 500 mg Tablets and Depakote® DR 500 mg Under Fasting Conditions.
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.
Read the detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex sodium DR 500 mg tablets of Dr.Reddy's Laboratories Limited, Generics, India comparing with that of Depakote® DR (containing Divalproex sodium) 500 mg tablets of Abbott Laboratories PR Ltd., Barceloneta, PR, in healthy, adult, human subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Divalproex Sodium
- Keywords
- Bioequivalence, Crossover, Divalproex Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex SodiumDrug
Also called Depakote DR 500 mg Tablets
Divalproex Sodium DR Tablets 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Divalproex Sodium DR Tablets 500 mg | Experimental | Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Divalproex Sodium |
| Depakote DR 500 mg Tablets | Active comparator | Depakote DR 500 mg Tablets of Abbott Laboratories PR Ltd., Receives: Drug: Divalproex Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startAug 2006
- Primary completionSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mohanlal Siva Prasad Sayana, Principal investigator, Bioserve Clinical Research Pvt. Ltd.,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132170
- Sponsor's protocol ID
- P-623/06-00
- Status last verified
- Jun 2010
- First submitted
- 26 May 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, 2-treatment, 2-period, 2-sequence, Single Dose, Crossover, Bioequivalence Study of Divalproex Sodium DR 500 mg Tablets and Depakote® DR 500 mg Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01132170
- Acronym / sponsor ID
- P-623/06-00
- Conditions
- Healthy
- Keywords
- Bioequivalence, Crossover, Divalproex Sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.
Detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex sodium DR 500 mg tablets of Dr.Reddy's Laboratories Limited, Generics, India comparing with that of Depakote® DR (containing Divalproex sodium) 500 mg tablets of Abbott Laboratories PR Ltd., Barceloneta, PR, in healthy, adult, human subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divalproex Sodium DR Tablets 500 mg | Experimental | Drug: Divalproex SodiumDivalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited |
| Depakote DR 500 mg Tablets | Active comparator | Drug: Divalproex SodiumDepakote DR 500 mg Tablets of Abbott Laboratories PR Ltd., |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- 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.
Key exclusion criteria (14 listed)
- 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:
- History of hypersensitivity or idiosyncratic reaction to Divalproex sodium or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divalproex SodiumAlso: Depakote DR 500 mg TabletsDivalproex Sodium DR Tablets 500 mg | Drug | Depakote DR 500 mg Tablets, Divalproex Sodium DR Tablets 500 mg |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohanlal Siva Prasad Sayana principal investigator
Bioserve Clinical Research Pvt. Ltd.,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Divalproex Sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax and AUC parameters (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.