Completed
A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
What is being tested
Data Collection
Who is being recruted
Bipolar and Related Disorders+1
+ Mental Disorders
+ Bipolar Disorder
From 25 to 45 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: October 2002
Summary
Principal SponsorRoxane Laboratories
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2002
Actual date on which the first participant was enrolled.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.
Official TitleA Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
Principal SponsorRoxane Laboratories
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 25 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bipolar and Related DisordersMental DisordersBipolar DisorderMood Disorders
Criteria
1 inclusion criteria required to participate
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
3 exclusion criteria prevent from participating
Participation in a clinicl trial within 30 days prior to study initiation.
Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center