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

NCT00776282 | Completed DMC

• 1 other identifier: 118_LORAT_06
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

bioequivalence loratadine 10 mg orally disintegrating; tablets fed conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

loratadine 10 mg orally disintegrating tablets

Drug: loratadine 10 mg orally disintegrating

2

ACTIVE COMPARATOR

loratadine 10 mg orally disintegrating tablets

Drug: loratadine 10 mg orally disintegrating

Interventions

loratadine 10 mg orally disintegrating DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Related Links

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MeSH Terms

Interventions

Loratadine

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: July 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 21, 2008

Record last verified: 2008-10