Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00951600
First received: July 31, 2009
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single- dose, crossover bioavailability study comparing oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in healthy, adult, male, human subjects under fasting conditions.


Condition Intervention
Healthy
Drug: oxcarbazepine 300 mg/5mL oral suspension

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Oxcarbazepine 300 mg/5mL Oral Suspension of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceuticals Inc) With Trileptal® 300 mg/5mL Oral Suspension (Containing Oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in Healthy, Adult, Male, Human Subjects Under Fasting Condition.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fasting condition [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2006
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oxcarbazepine oral suspension 300 mg/5mL of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
Drug: oxcarbazepine 300 mg/5mL oral suspension
Active Comparator: 2
Trileptal® (oxcarbazepine) oral suspension 300 mg/5mL of Novartis
Drug: oxcarbazepine 300 mg/5mL oral suspension

Detailed Description:

Following an overnight fast of at least 10 hours, a single dose of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension (containing oxcarbazepine 300 mg/5rnL) was administered using a 10 mL graduated syringe, during each period of the study under the supervision of trained study personnel, along with 240 mL of drinking water at ambient temperature.

During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.

A total of forty (40) subjects were administered a single oral dose of the test or reference formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension (containing oxcarbazepine 300 mg/5mL) according to a randomization schedule. Thirty-five (35) subjects completed both the periods of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Were in the age range of 18-45 years.
  2. Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  3. Had voluntarily given written informed consent to participate in this study
  4. 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.

There were no deviations in this regard.

Exclusion Criteria:

  1. History of hypersensitivity to oxcarbazepine, carbamazepine or to any related drugs.
  2. History of hyponatremia, diplopia.
  3. Recent history of dizziness, somnolence, and abdominal pain.
  4. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  5. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  6. 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.
  7. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
  8. 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.
  9. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
  10. Clinically abnormal ECG or Chest X-ray.
  11. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
  12. History of any psychiatric illness, which might impair the ability to provide written informed consent.
  13. Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
  14. 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 I glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
  15. Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  16. Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
  17. Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.

There were no deviations in this regard.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951600

Locations
India
Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited
Noida, Uttar Pradesh, India
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00951600     History of Changes
Other Study ID Numbers: 228_OXCAR_06
Study First Received: July 31, 2009
Last Updated: August 3, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by Ranbaxy Inc.:
Oxcarbazepine oral suspension fasting study

Additional relevant MeSH terms:
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014