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NCT00618111 · ClinicalTrials.gov registry record · NA
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT00618111: Completed NA study, sponsored by Roxane Laboratories.
NCT00618111 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00618111, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.
Interventions
- DRUG Granisetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2005-03 |
| Est. Completion | 2005-04 |
| Phase | NA |
What the finished NCT00618111 record still lists
NCT00618111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Granisetron is the first listed.
NCT00618111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00618111 about?
NCT00618111 is a clinical study titled "A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions". The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.
What is the current status of trial NCT00618111?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2005-03. Estimated completion is 2005-04.
What interventions are being tested in trial NCT00618111?
The interventions under investigation include: Granisetron (DRUG).
Who is sponsoring clinical trial NCT00618111?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00618111's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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