Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions
NCT ID: NCT00779831
Last Updated: 2008-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2004-06-30
2004-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
120 mg Pseudoephedrine hydrochloride extended release tablets of ranbaxy
120 mg Pseudoephedrine hydrochloride extended release tablets
2
(Sudafed ® 12 hour) 120 mg Pseudoephedrine hydrochloride extended - release tablets
120 mg Pseudoephedrine hydrochloride extended release tablets
Interventions
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120 mg Pseudoephedrine hydrochloride extended release tablets
Eligibility Criteria
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Exclusion Criteria
1. Healthy adult male or female volunteers , 18 to 55 years of age
2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983)
3. Medically healthy subjects with clinically normal laboratory profiles and ECGs
4. 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:
1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum
2. IUD in place for at least 3 months
3. Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study
4. Surgical sterilization of the partner (vasectomy for 6 months minimum)
5. Hormonal contraceptives for at least 3 months prior to the first dose of the study
6. Other birth control methods may be deemed acceptable
5. Post menopausal women with amenorrhea for at least 2 years will be eligible
6. Voluntarily consent to participate in the study
* Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
2. In addition, history or presence of:
1. Alcoholism or drug abuse within the past year
2. Hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other sympathomimetic amines
3. Glaucoma or hypermetropia
3. Female subjects who are pregnant or lactating
4. Positive results on HIV, HbsAg and HCV tests
5. Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor, or any sympathomimetic amines
6. Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study
7. Subjects who through completion of the study, would have donated in excess of:
* 500 mL of blood in 14 days
* 1500 mL of blood in 180 days
* 2500 mL of blood in 1 year. 8. Subjects who have participated in another clinical trial within 28 days prior to the first dose.
18 Years
55 Years
ALL
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research labs
Locations
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MDS Pharma Services
Saint-Laurent, Quebec, Canada
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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AA16795
Identifier Type: -
Identifier Source: org_study_id