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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00837915
First received: January 8, 2009
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

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 fasting 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
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

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837915

Locations
Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00837915     History of Changes
Other Study ID Numbers: AA01111
Study First Received: January 8, 2009
Last Updated: February 5, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Pseudoephedrine
Ephedrine
Loratadine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Stimulants
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on September 16, 2014