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NCT00863902 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Non-fasting Conditions
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00863902 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 26 participants.
The verdict
NCT00863902, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Cetirizine Hydrochloride 10 mg tablets, single dose
- DRUG Zyrtec® 10 mg tablets, single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-08 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00863902
The ClinicalTrials.gov registry entry for NCT00863902 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cetirizine Hydrochloride 10 mg tablets, single dose is the first listed.
NCT00863902 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00863902 about?
NCT00863902 is a clinical study titled "A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Non-fasting Conditions". 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.
What is the current status of trial NCT00863902?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-08. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00863902?
The interventions under investigation include: Cetirizine Hydrochloride 10 mg tablets, single dose (DRUG), Zyrtec® 10 mg tablets, single dose (DRUG).
Who is sponsoring clinical trial NCT00863902?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
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