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Completed

NCT Number: NCT00602394

Bioequivalency Study of 300 mg Lithium Carbonate Under Fed 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 fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042

Houston, Texas, 77042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to lithium, or any comparable or similar product.

Treatment and study plan

Lithium

Drug

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two period, Fourteen day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jan 28, 2008
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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