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Clinical trial

A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder

NCT07540338 is registered in ClinicalTrials.gov with Alzamend Neuro, Inc. as lead sponsor.

NCT NCT07540338
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
Lead sponsor
Alzamend Neuro, Inc.
Phase
Phase 1/2
Overall status
Recruiting
Start date
May 11, 2026
Completion date
December 31, 2026
Enrollment
20 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bipolar i disorder