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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649376 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Fexofenadine Tablets 180 mg Drug: Allegra® Tablets 180 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 Fexofenadine Tablets (180 mg; Mylan) and Allegra® Tablets (180 mg; Aventis) in Healthy Adult Volunteers |
| Enrollment: | 68 |
| Study Start Date: | October 2003 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Fexofenadine Tablets 180 mg
|
Drug: Fexofenadine Tablets 180 mg
180mg, single dose fasting
|
|
2: Active Comparator
Allegra® Tablets 180 mg
|
Drug: Allegra® Tablets 180 mg
180mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or 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:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | FEXO-0351 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649376 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Histamine Antagonists Fexofenadine Histamine phosphate |
Histamine H1 Antagonists Anti-Allergic Agents Healthy Histamine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Histamine Antagonists Therapeutic Uses Physiological Effects of Drugs Fexofenadine |
Histamine Agents Histamine H1 Antagonists Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Pharmacologic Actions |