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NCT00649857 · ClinicalTrials.gov registry record · Phase 1
Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00649857: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00649857 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00649857, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed conditions.
Interventions
- DRUG Cetirizine HCl Tablets 10 mg
- DRUG Zyrtec® 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2002-11 |
| Est. Completion | 2002-12 |
| Phase | Phase 1 |
What the finished NCT00649857 record still lists
NCT00649857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetirizine HCl Tablets 10 mg is the first listed.
NCT00649857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00649857 about?
NCT00649857 is a clinical study titled "Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg". The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed conditions.
What is the current status of trial NCT00649857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2002-11. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00649857?
The interventions under investigation include: Cetirizine HCl Tablets 10 mg (DRUG), Zyrtec® 10 mg (DRUG).
Who is sponsoring clinical trial NCT00649857?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00649857's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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