Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition

NCT00951847 | Completed DMC

• 1 other identifier: 233_OXCAR_06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation, USA in healthy, adult, male, human subjects under fed conditions.

Conditions

Healthy

Keywords

Oxcarbazepine oral suspension fed study

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fed condition

Study Arms (2)

1

EXPERIMENTAL

Oxcarbazepine oral suspension 300 mg/5 mL of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)

Drug: oxcarbazepine 300 mg/5 mL oral suspension

2

ACTIVE COMPARATOR

Trileptal® (oxcarbazepine) oral suspension 300 mg/5 mL of Novartis

Drug: oxcarbazepine 300 mg/5 mL oral suspension

Interventions

oxcarbazepine 300 mg/5 mL oral suspension DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Were in the age range of 18-45 years.
• Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
• Had voluntarily given written informed consent to participate in this study.
• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
• Had a non-vegetarian diet habit.
• There were no deviations in this regard.

You may not qualify if:

• History of hypersensitivity to oxcarbazepine, carbamazepine or to any related drugs.
• History of hyponatremia, diplopia.
• Recent history of dizziness, somnolence, and abdominal pain.
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.
• Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
• Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
• Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
• Clinically abnormal ECG or Chest X-ray.
• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
• History of any psychiatric illness, which might impair the ability to provide written informed consent.
• Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
• History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
• Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Noida, Uttar Pradesh, India

Location

Related Links

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MeSH Terms

Interventions

Oxcarbazepine; Suspensions

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: October 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 4, 2009

Record last verified: 2009-08

Locations

IN (1)