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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Healthy Donors
• Intervention / Treatment: Drug: Theralite®; Drug: Actilitio®

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 111156
      • Centro de Atención e Investigación Médica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• - Men or women between 18 and 50 years of age at the time of signing the informed consent form.
• Women who are unable to conceive, who are not pregnant or breastfeeding (To be considered unable to conceive, they must be at least 1 year postmenopausal or surgically sterile). Table 2.
• Female participants of childbearing capacity must be using adequate contraception for the past 6 months and agree to continue using an adequate contraceptive method for 30 days after signing the consent form
• Have been clinically diagnosed as healthy by the study physician.
• Subjects with clinical laboratory results within normal ranges and/or fit by medical screening. (Table 2)
• Subjects were non-smokers for the last 3 months at the time of screening.
• Having signed the informed consent for the study.
• Body mass index between 18-30 kg/m2.
• Subject with complete contact information (cell phone and/or landline contact, address).
• Subject who has a family member or guardian with a contact telephone number.
• Subject with the availability of time to comply with the scheduled visits and activities.
• Subject who is willing to comply with the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

• - Subject diagnosed with renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological, psychiatric, compulsive depressive disorder.
• Subjects with a diagnosis of hematological disorders, such as anemia and/or polycythemia.
• Subjects with history of gastric surgeries.
• Permanent or temporary use of any type of medication either on their own initiative or by medical prescription 2 days prior to the hospitalization phase of the study. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the beginning of the present study.
• Smoking in the last 3 months, regardless of the number of cigarettes at the time of selection.
• Drinking alcohol in excess of 16 g 15 days prior to selection as a subject, this amount being equivalent to 1 beer or 2 glasses of wine.
• Positive test for the consumption of drugs of abuse or psychoactive substances at the time of selection (Table 2).
• Known hypersensitivity to the active substance or excipients of the test product.
• Medical history of angioedema or anaphylaxis.
• Pregnant or lactating woman.
• Subject diagnosed with human immunodeficiency virus infection, hepatitis B or hepatitis C positive.
• Having participated in clinical studies in the 4 months prior to the start of the present study.
• Having donated blood or having reported blood loss greater than 500 mL in the previous 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Period 1; Theralite® 300 mg	Drug: Theralite®; Reference; Other Names: lithium carbonate; Drug: Actilitio®; Test; Other Names: lithium carbonate
Active Comparator: Period 2; Actilitio® 300 mg	Drug: Theralite®; Reference; Other Names: lithium carbonate; Drug: Actilitio®; Test; Other Names: lithium carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	concentration plasma under curve AUC	0 hours - 72 hours
Cmax	peak concentration plasma Cmax	0 hours - 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Pharmacokinetic Outcome Measures	0 hours - 6 hours

Collaborators and Investigators

• Sponsor: Centro de Atencion e Investigacion Medica

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: bioequivalence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: CGIS-BIO-001-2019; Actifarma (Other Identifier: Caimed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: jul 2024 - abril 2025
• IPD Sharing Access Criteria: indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No