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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00776282
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Information provided by:
Ranbaxy Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: loratadine 10 mg orally disintegrating Not Applicable

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 mg orally disintegrating tablets of Ohm Laboratories, Inc. (A subsidiary of Ranbaxy pharmaceuticals Inc. USA) with Claritin® Reditabs® 10 mg Tablet (containing loratadine 10 mg) of Schering- Plough Healthcare Product Inc, USA. in healthy, adult, male, human subjects under fed condition.

A single oral dose of loratadine 10 mg orally disintegrating tablets was administered under low light condition during each period of the study under supervision of a trained medical officer.

Subjects were instructed to completely dissolve the tablet on the tongue before swallowing the saliva and then, 240 mL of water was administered 30 seconds after drug administration.

During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.

A total of 80 subjects were randomized to receive single oral dose of Loratadine 10mg and Subjects were admitted in two groups of equal size. Group I: 1-40 Group II: 41-80 70 subjects completed both the periods of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open Label, Balanced, Randomized, Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover, Bioavailability Study on Loratadine Formulations Comparing Loratadine 10 mg Orally Disintegrating Tablets of Ohm Laboratories, Inc. (A Subsidiary of Ranbaxy Pharmaceuticals Inc) With Claritin® Reditabs® 10 mg Tablet (Containing Loratadine 10 mg) of Schering- Plough Healthcare Product Inc, in Healthy, Adult, Male, Human Subjects Under Fed Condition
Study Start Date : July 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Loratadine

Arm Intervention/treatment
Experimental: 1
loratadine 10 mg orally disintegrating tablets
Drug: loratadine 10 mg orally disintegrating
Active Comparator: 2
loratadine 10 mg orally disintegrating tablets
Drug: loratadine 10 mg orally disintegrating

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
Additional Information:
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Responsible Party: Dr. tausif monif, Ranbaxy Research Laboratories Identifier: NCT00776282    
Other Study ID Numbers: 118_LORAT_06
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008
Keywords provided by Ranbaxy Inc.:
bioequivalence loratadine 10 mg orally disintegrating
tablets fed conditions
Additional relevant MeSH terms:
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Pathologic Processes
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs