NCT06861842

Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Centro de Atencion e Investigacion Medica · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition

Detailed description

A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition, following the design: Open-label, crossover, randomized, single-dose design of 300 mg lithium carbonate immediate release tablets, with two treatments, two periods, two sequences in fasting condition, with a washout time of 14 days between each dose, participation as a subject in these studies implies a higher than minimal risk for the subjects.

Conditions

• Healthy
• Healthy Donors

Interventions

Type	Name	Description
DRUG	Theralite®	Reference
DRUG	Actilitio®	Test

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: Colombia