Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Divalproex Sodium

• Registration Number: NCT01581788
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure the safety of subjects.

Detailed Description

Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Divalproex Sodium Extended Release Tablets 500 mg of Dr. Reddy's Laboratories Limited, and Depakote ER 500 mg mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-19
• Last Update Submitted: 2012-04-19
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

The subjects were selected for study participation, if they met the following criteria:

1. Subjects aged between 18 and 45 years (both inclusive).
2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
4. Subjects having normal 12-lead electrocardiogram (ECG).
5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria

The subjects were excluded from the study, if they met any of the following criteria:

1. Hypersensitivity to Divalproex or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
4. History or presence of significant alcoholism or drug abuse.
5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
6. History or presence of asthma, urticaria or other significant allergic reactions.
7. History or presence of significant gastric and/or duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or capsules.
12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
13. Major illness during 3 months before screening.
14. Participation in a drug research study within past 3 months.
15. Donation of blood in the past 3 months before screening.
16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
18. History or presence of significant easy bruising or bleeding.
19. History or presence of significant recent trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Depakote ER Tablets, 500 mg	Divalproex Sodium	Depakote ER Tablets, 500 mg of Abbott Laboratories
Divalproex Sodium ER Tablets, 500 mg	Divalproex Sodium	Divalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC)	Pre-dose 1 hour, 1.50, 3, 4.50, 6, 7.50, 9, 10.50, 12, 13.50, 15, 16.50, 18, 19.50, 21, 22.50, 24, 25.50, 27, 32, 36, 48, 60, 72, 96 hours post-dose

Trial Locations

Locations (1)

Veeda Clinical Research, India; 🇮🇳 Ahmedabad, Gujrat, India