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Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00845546
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Ranbaxy Inc.

Study Description
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Brief Summary:
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets Not Applicable

Detailed Description:

The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way Crossover Study to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin_D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in Healthy adult Volunteers Under Fed Conditions In each period, subjects were housed from the evenings before the dosing until after the 36 hour blood draw and were to return for subsequent blood draws at 48, 72, 96 and 120 hours post dose. Single oral 10 mg Loratadine/ 240 mg Pseudoephedrine Sulfate doses were separated by a washout period of 21 days.

A total of 40 subjects and 1 alternate (34 males and 7 females) were included in this study, of which 37 (32 males and 5 females) finished the study according to the protocol.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in Healthy Adult Volunteers Under Fed Conditions
Study Start Date : June 2002
Actual Primary Completion Date : August 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets of Ranbaxy
 Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets
Active Comparator: 2
(Claritin_D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets
 Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fed conditions

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

Inclusion Criteria:

  • Healthy adult male or female volunteers, 18-45 years of agestart of the study.
  • Other birth control methods may be deemed acceptable
  • Postmenopausal women with amenorrhea for at least 2 years will be eligible
  • Voluntarily consent to participate in the study

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease

  • In addition, history or presence of:

    • alcoholism or drug abuse within the past year
    • hypersensitivity or idiosyncratic reaction to Loratadine or any other H1-receptor antagonist
    • hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other sympathomimetic amines
  • Glaucoma or hypermetropia
  • Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor, or any sympathomimetic amines
  • Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start
  • Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start
  • Female subjects who are pregnant or lactating
  • Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dose

  • Subjects who, through completion of the study, would have donated in excess of:

    • 500 mL of blood in 14 days
    • 500-750 mL of blood in 14 days (unless approved by the principal Investigator)
    • 1000 mL of blood in 90 days
    • 1250 mL of blood in 120 days
    • 1500 mL of blood in 180 days
    • 2000 mL of blood in 270 days
    • 2500 mL of blood in 1 days
  • Subjects who have participated in another clinical trial within 28 days prior to the study start
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845546


Locations
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Canada, Quebec
MDS Pharma Services
St. Laurent, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited
More Information
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Additional Information:
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Responsible Party: Dr. Tausif Monif, Ranbaxy Research labs
ClinicalTrials.gov Identifier: NCT00845546     History of Changes
Other Study ID Numbers: AA01112
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009
Keywords provided by Ranbaxy Inc.:
Bioequivalence 10 mg Loratadine 240 mg Pseudoephedrine Sulfate Extended Release Tablets
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Loratadine
Pseudoephedrine
Ephedrine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
 Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents