Trials / Completed
CompletedNCT00601536
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 39 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lithium |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2003-05-01
- Completion
- 2003-05-01
- First posted
- 2008-01-28
- Last updated
- 2018-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00601536. Inclusion in this directory is not an endorsement.