Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions
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.
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jun 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 23, 2008
CompletedFirst Posted
Study publicly available on registry
October 24, 2008
CompletedOctober 24, 2008
October 1, 2008
Same day
October 23, 2008
October 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence
Study Arms (2)
1
EXPERIMENTAL120 mg Pseudoephedrine hydrochloride extended release tablets of ranbaxy
2
ACTIVE COMPARATOR(Sudafed ® 12 hour) 120 mg Pseudoephedrine hydrochloride extended - release tablets
Interventions
Eligibility Criteria
You may not qualify if:
- Subjects were included in the study if they met all of the following criteria:
- Healthy adult male or female volunteers , 18 to 55 years of age
- 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)
- Medically healthy subjects with clinically normal laboratory profiles and ECGs
- 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:
- 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 first dose and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum)
- Hormonal contraceptives for at least 3 months prior to the first dose of the study
- Other birth control methods may be deemed acceptable
- Post menopausal women with amenorrhea for at least 2 years will be eligible
- 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:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MDS Pharma Services
Saint-Laurent, Quebec, H4R2N6, Canada
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 23, 2008
First Posted
October 24, 2008
Study Start
June 1, 2004
Primary Completion
June 1, 2004
Study Completion
December 1, 2004
Last Updated
October 24, 2008
Record last verified: 2008-10