Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting conditions.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Fasted Normal,Healthy subjects.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Desloratadine Tablets, 5 mg Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories |
Drug: Desloratadine
Desloratadine Tablets, 5 mg
Other Names:
|
Active Comparator: Clarinex Clarinex® 5 mg Tablets of Schering-Plough |
Drug: Desloratadine
Desloratadine Tablets, 5 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Bioavailability is based on Cmax and AUC parameters [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Is the individual a healthy, normal adult man and women who volunteers to participate?
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Is s/he within 18 and 45 years of age, inclusive?
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Is his/her BMI between 19 and 30, inclusive?
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Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study?
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Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
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Has s/he provided written informed consent?
A no answer to any of the above questions indicates that the individual is ineligible for enrollment
Exclusion Criteria:
Does the individual have a history of allergy or hypersensitivity to desloratadine?
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Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
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Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
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Is she nursing?
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Does s/he have serious psychological illness?
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Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
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Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test?
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Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? .
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Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
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Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
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Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
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Has s/he donated plasma during the two week period preceding study initiation?
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Has s/he used any tobacco products in the 3 months preceding drug administration?
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Has s/he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | SFBC, Ft. Myers, Inc., | Ft. Myers | Florida | United States | 33901 |
Sponsors and Collaborators
- Dr. Reddy's Laboratories Limited
Investigators
- Principal Investigator: Antonio R. Pizarro, M.D.,, SFBC Ft. Myers, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 50485