Status:
COMPLETED
Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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 Table...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Healthy adult male or female volunteers, 18-45 years of agestart of the study.
- Other birth control methods may be deemed acceptable
- Postmenopausal women with amenorrhea for at least 2 years will be eligible
- Voluntarily consent to participate in the study
Exclusion
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- In addition, history or presence of:
- alcoholism or drug abuse within the past year
- hypersensitivity or idiosyncratic reaction to Loratadine or any other H1-receptor antagonist
- hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other sympathomimetic amines
- Glaucoma or hypermetropia
- Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor, or any sympathomimetic amines
- Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start
- Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start
- Female subjects who are pregnant or lactating
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dose
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days
- 500-750 mL of blood in 14 days (unless approved by the principal Investigator)
- 1000 mL of blood in 90 days
- 1250 mL of blood in 120 days
- 1500 mL of blood in 180 days
- 2000 mL of blood in 270 days
- 2500 mL of blood in 1 days
- Subjects who have participated in another clinical trial within 28 days prior to the study start
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00845546
Start Date
June 1 2002
End Date
November 1 2002
Last Update
February 18 2009
Active Locations (1)
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1
MDS Pharma Services
Saint-Laurent, Quebec, Canada, H4R 2N6