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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650065 |
"The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10 mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cetirizine HCl Tablets 10 mg Drug: Zyrtec® Tablets 10 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Cetirizine HCl Tablets (10 mg; Mylan) and Zyrtec® Tablets (10 mg; Pfizer) in Healthy Volunteers |
Enrollment: | 26 |
Study Start Date: | November 2002 |
Study Completion Date: | December 2002 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Cetirizine HCl Tablets 10 mg
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Drug: Cetirizine HCl Tablets 10 mg
10mg, single dose fasting
|
2: Active Comparator
Zyrtec® Tablets 10 mg
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Drug: Zyrtec® Tablets 10 mg
10mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and non-pregnant, non-lactating female
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 |
Principal Investigator: | So Ran Hong, M.D. | Novum Pharmaceutical Research Services |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | CETI-0286 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650065 |
Health Authority: | United States: Institutional Review Board |
Histamine phosphate Healthy Cetirizine Histamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Histamine Antagonists Therapeutic Uses Physiological Effects of Drugs |
Histamine Agents Histamine H1 Antagonists Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Pharmacologic Actions |