Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions

February 5, 2009 updated by: Ranbaxy Laboratories Limited

Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy Adult Volunteers Under Fasting Conditions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy adult Volunteers Under Fasting Conditions A total of 40 subjects (30 males and 10 females) were included in this study, of which 36 (27 males and 9 females) finished the study according to the protocol.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4R2N6
        • MDS Pharma Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult male or female volunteers, 18-45 years of age
  • Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with clinically normal laboratory profiles;

  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:

    • surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum
    • IUD in place for at least 3 months
    • barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and .throughout the study
    • surgical sterilization of the partner (vasectomy for 6 months minimum
    • hormonal contraceptives for at least 3 months prior to the start 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:

  • Subject candidates must not be enrolled in the study if they meet any of the following 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 loratidine or any other H1-receptor antagonist
    • hypersensitivity or idiosyncratic reaction to pseudoephederine or any other sympatomimetic 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 completition of the study, would have donated in excess of:

    • 500 mL of blood in 14 days, or
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets of Ranbaxy
Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets
Active Comparator: 2
(Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets
Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fasting conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA01111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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