Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed Conditions

Inclusion Criteria: * Were in the age range of 18-45 years. * Were neither overweight nor underweight for his 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 non-vegetarian dietary habit Exclusion Criteria: * Had history of allergy to loratadine. * Had history of hypertension * Had Concurrently used enzyme modifying drugs especially erythromycin, MAO inhibitors, ketoconazole, and cimetidine * Had recent history of abdominal pain, epistaxis or sleep disturbances * Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. * Had presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses or syphilis infection. * Had presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count. * Had been positive for urinary screen testing of drugs of abuse (opiates or cannabinoids). * Had presence of values, which are 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. * If there was any clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), epithelial cells, casts, crystals, glucose (positive) or protein (positive). * Had clinically abnormal ECG or Chest X-ray. * Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma. * 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 have difficulty in abstaining for the duration of each study period. * Had history of any psychiatric illness, which may impair the ability to provide, written informed consent. * Were regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period. * Used 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.