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
Overview
- Phase
- Not Applicable
- Intervention
- oxcarbazepine 300 mg/5 mL oral suspension
- Conditions
- Healthy
- Sponsor
- Ranbaxy Laboratories Limited
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fed condition
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
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 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. Following an overnight fast of at least 10 hours, all subjects were served a high-fat high calorie breakfast. Thirty minutes after the start of the meal, a single oral dose of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension 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 enrolled into the study, to be administered a single oral dose of the test or reference formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension according to a randomization schedule. Thirty-three (33) subjects completed both the periods of the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
1
Oxcarbazepine oral suspension 300 mg/5 mL of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
Intervention: oxcarbazepine 300 mg/5 mL oral suspension
2
Trileptal® (oxcarbazepine) oral suspension 300 mg/5 mL of Novartis
Intervention: oxcarbazepine 300 mg/5 mL oral suspension
Outcomes
Primary Outcomes
Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fed condition