Status:
COMPLETED
Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
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 Tr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00951847
Start Date
October 1 2006
End Date
December 1 2006
Last Update
August 4 2009
Active Locations (1)
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1
Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited
Noida, Uttar Pradesh, India