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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00845546 |
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 |
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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 |
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 |
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1: Experimental
10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets of Ranbaxy
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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 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
In addition, history or presence of:
Subjects who, through completion of the study, would have donated in excess of:
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 |
Bioequivalence 10 mg Loratadine 240 mg Pseudoephedrine Sulfate Extended Release Tablets |
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 |
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 |