Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions

NCT00776217 | Completed DMC

• 1 other identifier: 213_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 (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.

Conditions

Healthy

Keywords

bioequivalence loratadine 10 mg orally disintegrating tablets fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

loratadine 10 mg orally disintegrating tablets

Drug: loratadine 10 mg orally disintegrating tablets

2

ACTIVE COMPARATOR

loratadine 10 mg orally disintegrating tablets

Drug: loratadine 10 mg orally disintegrating tablets

Interventions

loratadine 10 mg orally disintegrating tablets DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Related Links

• Related Info
• Related Info
• Related Info

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: June 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 21, 2008

Record last verified: 2008-10