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NCT00601536 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
A NA study of Bipolar Disorder, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT00601536 is a NA study of Bipolar Disorder that has completed, run by Roxane Laboratories. The registered enrollment target is 29 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.
The verdict
NCT00601536, a NA study of Bipolar Disorder, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.
Conditions Studied
Interventions
- DRUG Lithium
Study Locations (1)
Pennsylvania
- Novum Pharmaceutical Research Services - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2003-04 |
| Est. Completion | 2003-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00601536
The ClinicalTrials.gov registry entry for NCT00601536 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
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.
NCT00601536 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00601536 about?
NCT00601536 is a clinical study titled "Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions". The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.
What is the current status of trial NCT00601536?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2003-04. Estimated completion is 2003-05.
What conditions does trial NCT00601536 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00601536?
The interventions under investigation include: Lithium (DRUG).
Who is sponsoring clinical trial NCT00601536?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00601536 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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