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NCT00602381 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
A NA study of Bipolar Disorder, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00602381: Completed NA study of Bipolar Disorder, sponsored by Roxane Laboratories.
NCT00602381 is a NA study of Bipolar Disorder that has completed, run by Roxane Laboratories. The registered enrollment target is 30 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602381, a NA study of Bipolar Disorder, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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 fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.
Conditions Studied
Interventions
- DRUG Lithium
Study Locations (1)
Arkansas
- Arkansas Research - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-11 |
| Est. Completion | 2002-11 |
| Phase | NA |
What the finished NCT00602381 record still lists
NCT00602381 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 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Lithium is the first listed.
NCT00602381 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT00602381 about?
NCT00602381 is a clinical study titled "Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting 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 fasting conditions using a single-dose, randomized, three-treatment, three-period, s...
What is the current status of trial NCT00602381?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2002-11. Estimated completion is 2002-11.
What conditions does trial NCT00602381 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00602381?
The interventions under investigation include: Lithium (DRUG).
Who is sponsoring clinical trial NCT00602381?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602381 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00602381's enrollment target sits among peer trials
30 136th of 162 higher than 18 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder 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.
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