Clinical trial NCT01132196: Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions
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 Fed Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Crossover
Divalproex Sodium
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-05-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 fed conditions.

Eligibility criteria: 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 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.
* 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.

Primary outcomes:
measure: Bioequivalence based on Cmax and AUC parameters
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Bioserve Clinical Research Pvt. Ltd.,
state: Andhra Pradesh
Study officials:
affiliation: Bioserve Clinical Research Pvt. Ltd.,
name: Mohanlal Siva Prasad Sayana
role: PRINCIPAL_INVESTIGATOR
References: