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Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00779805 |
The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.
Condition | Intervention |
---|---|
Healthy |
Drug: Pseudoephedrine hydrochloride 120 mg ER tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With Sudafed 120 mg ER Tablets of Pfizer Consumer Health Care in Healthy, Adult, Human Subjects Under Fed Conditions. |
Enrollment: | 40 |
Study Start Date: | June 2004 |
Study Completion Date: | October 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy
|
Drug: Pseudoephedrine hydrochloride 120 mg ER tablets |
2: Active Comparator
Sudafed 120 mg ER tablets
|
Drug: Pseudoephedrine hydrochloride 120 mg ER tablets |
This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioavailability study planned on 40 healthy, adult, human subjects under fed conditions. A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects completed both the periods of the study.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 016/ PSEUD-120/ 04 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779805 History of Changes |
Health Authority: | India: Drugs Controller General of India |
Bioequivalence Pseudoephedrine hydrochloride 120 mg ER tablets |
Pseudoephedrine Neurotransmitter Agents Adrenergic Agents Anti-Asthmatic Agents Central Nervous System Stimulants Healthy Cardiovascular Agents Nasal Decongestants |
Oxymetazoline Malnutrition 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 |