NCT00601575

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2002

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

September 19, 2007

Last Update Submit

January 19, 2018

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

    Baseline, Three period, Fourteen day washout

Interventions

LithiumDRUG

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Research

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Jerry Herron, MD

    Arkansas Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2007

First Posted

January 28, 2008

Study Start

October 1, 2002

Primary Completion

October 1, 2002

Study Completion

November 1, 2002

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)