Status:
COMPLETED
Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with Claritin® Reditabs® (cont...
Detailed Description
The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study on loratadine formulation comparing loratadine 10...
Eligibility Criteria
Inclusion
- Aged 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.
Exclusion
- Had history of allergy to loratadine.
- Had history of hypertension.
- Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
- Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Had 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.
- Was positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
- Had 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.
- Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
- Had clinically abnormal ECG or Chest X-ray.
- Had history of any psychiatric illness, which might impair the ability to provide written informed consent
- Was a regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
- Had 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.
- Used any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- Had participated 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00776217
Start Date
June 1 2006
End Date
September 1 2006
Last Update
October 21 2008
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