![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
Actavis Inc. |
---|---|
Information provided by: | Actavis Inc. |
ClinicalTrials.gov Identifier: | NCT00863902 |
To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cetirizine Hydrochloride 10 mg tablets, single dose Drug: Zyrtec® 10 mg tablets, single dose |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers |
Enrollment: | 26 |
Study Start Date: | August 2006 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Cetirizine Hydrochloride 10 mg tablets, single dose
|
Drug: Cetirizine Hydrochloride 10 mg tablets, single dose
A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions
|
B: Active Comparator
Zyrtec® 10 mg tablets, single dose
|
Drug: Zyrtec® 10 mg tablets, single dose
B: Active comparator Subjects received Pfizer Inc. formulated products under fed conditions
|
Study Type: Interventional Study Design: Single-dose two-way, crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test (Treatment A) and study reference (Treatment B).
Official Title: Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
AAIPharma Inc.- AAI Clinic | |
Morrisville, North Carolina, United States, 27560 |
Principal Investigator: | Evin H. Sides III,, MD | AAI Clinic (AAIPharma Inc.) |
Responsible Party: | Actavis Inc ( Zaidoon A. Al-Zubaidy, Senior Director, Biopharmaceutics ) |
Study ID Numbers: | AAI-US-431 |
Study First Received: | March 17, 2009 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00863902 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Cetirizine Healthy subjects |
Neurotransmitter Agents Histamine Antagonists Histamine phosphate Histamine H1 Antagonists |
Anti-Allergic Agents 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 Cetirizine Pharmacologic Actions |