- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132183
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
An Open Label, Balanced, Randomized, Two-treatment, Single-dose, Crossover, Bioequivalence Study of Divalproex Sodium Coated Particles in Capsules, 125 mg With Depakote® Sprinkle 125 mg in Healthy Human Subjects Under Fasting Conditions.
Study Overview
Detailed Description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions with an adequate washout period of 10 days.
The subjects were given a single oral dose of medication (test study or reference medication) . The capsule was opened and all the contents were sprinkled over a spoonful of applesauce without a spillage and administered to the subjects.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Andhra Pradesh
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Hyd, Andhra Pradesh, India, 500 037
- Bioserve Clinical Research Pvt. Ltd.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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 or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or 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 or above 100/min.
- History of hypersensitivity or idiosyncratic reaction to Investigational drug products 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.
- Subj eets 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Divalproex Sodium
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
|
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other Names:
|
ACTIVE_COMPARATOR: Depakote Sprinkle
Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA
|
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on Cmax and AUC parameters
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-638/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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