Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: oxcarbazepine 300 mg/5mL oral suspension (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fasting condition
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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.
Locations and Contacts
Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited, Noida, Uttar Pradesh, India
Additional Information
Starting date: September 2006
Last updated: August 3, 2009
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