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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) with Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc., USA in healthy, adult, human male subjects under fed condition.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Loratadine

Criteria

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.