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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00951847
• Date of registration: 31/07/2009
• Prospective Registration: No
• Primary sponsor: Ranbaxy Laboratories Limited
• Public title: Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition
• Scientific 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 Fed Condition
• Date of first enrolment: October 2006
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00951847
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

India

Key inclusion & exclusion 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.

5. Had a non-vegetarian diet habit.

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 1 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: oxcarbazepine 300 mg/5 mL oral suspension

Primary Outcome(s)

Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fed condition [Time Frame: No]

Secondary ID(s)

233_OXCAR_06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors