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Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions
This study has been completed.
First Received: January 8, 2009   Last Updated: February 16, 2009   History of Changes
Sponsored by: Ranbaxy Laboratories Limited
Information provided by: Ranbaxy Inc.
ClinicalTrials.gov Identifier: NCT00845546
  Purpose

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 Intervention
Healthy
Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets

Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fed conditions [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2002
Study Completion Date: November 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets of Ranbaxy
Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets
2: Active Comparator
(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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845546

Locations
Canada, Quebec
MDS Pharma Services
St. Laurent, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Ranbaxy Research labs ( Dr. Tausif Monif )
Study ID Numbers: AA01112
Study First Received: January 8, 2009
Last Updated: February 16, 2009
ClinicalTrials.gov Identifier: NCT00845546     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Ranbaxy Inc.:
Bioequivalence 10 mg Loratadine 240 mg Pseudoephedrine Sulfate Extended Release Tablets

Study placed in the following topic categories:
Pseudoephedrine
Neurotransmitter Agents
Adrenergic Agents
Anti-Asthmatic Agents
Central Nervous System Stimulants
Anti-Allergic Agents
Healthy
Cardiovascular Agents
Histamine
Nasal Decongestants
Oxymetazoline
Malnutrition
Histamine Antagonists
Loratadine
Phenylephrine
Vasoconstrictor Agents
Histamine phosphate
Histamine H1 Antagonists
Antipruritics
Ephedrine
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nasal Decongestants
Loratadine
Therapeutic Uses
Vasoconstrictor Agents
Antipruritics
Dermatologic Agents
Pseudoephedrine
Sympathomimetics
Histamine Agents
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents
Anti-Allergic Agents
Pharmacologic Actions
Histamine Antagonists
Autonomic Agents
Histamine H1 Antagonists
Ephedrine
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 01, 2009