Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting 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 (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 fasting condition.

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

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Loratadine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.