Trials / Completed
CompletedNCT00601575
Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 25 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lithium |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2002-10-01
- Completion
- 2002-11-01
- First posted
- 2008-01-28
- Last updated
- 2018-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00601575. Inclusion in this directory is not an endorsement.