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NCT00601575 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT00601575: Completed NA study, sponsored by Roxane Laboratories.
NCT00601575 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 30 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
NCT00601575, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.
Interventions
- DRUG Lithium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-10 |
| Est. Completion | 2002-11 |
| Phase | NA |
What the finished NCT00601575 record still lists
NCT00601575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 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 Lithium is the first listed.
NCT00601575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601575 about?
NCT00601575 is a clinical study titled "Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions". The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-s...
What is the current status of trial NCT00601575?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2002-10. Estimated completion is 2002-11.
What interventions are being tested in trial NCT00601575?
The interventions under investigation include: Lithium (DRUG).
Who is sponsoring clinical trial NCT00601575?
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 NCT00601575's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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