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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00779831 |
Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg (Warner-Lambert) under fasting conditions.
Condition | Intervention |
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Healthy |
Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions. |
Enrollment: | 36 |
Study Start Date: | June 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
120 mg Pseudoephedrine hydrochloride extended release tablets of ranbaxy
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Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets |
2: Active Comparator
(Sudafed ® 12 hour) 120 mg Pseudoephedrine hydrochloride extended - release tablets
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Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets |
This was an open label, randomized, single dose, 2-way crossover, relative bioavailability study performed on a total of 36 healthy adult subjects (20 males and 16 females). Thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36 hour blood draw. Single oral 120 mg Pseudoephedrine hydrochloride doses were separated by a washout period of 7 days. A total of thirty six (36) subjects (20 males and 16 females) were enrolled in the study. Out of which a total of thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects were included in the study if they met all of the following criteria:
Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
Exclusion Criteria:
Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
In addition, history or presence of:
Responsible Party: | Ranbaxy Research labs ( Dr. Tausif Monif ) |
Study ID Numbers: | AA16795 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779831 History of Changes |
Health Authority: | Canada: Health Canada |
Bioequivalence Pseudoephedrine hydrochloride 120 mg extended release tablets |
Pseudoephedrine Neurotransmitter Agents Adrenergic Agents Anti-Asthmatic Agents Central Nervous System Stimulants Healthy Cardiovascular Agents |
Nasal Decongestants Oxymetazoline Phenylephrine Vasoconstrictor Agents Ephedrine Peripheral Nervous System Agents Bronchodilator Agents |
Pseudoephedrine Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Physiological Effects of Drugs Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents |
Pharmacologic Actions Nasal Decongestants Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Ephedrine Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |