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

NCT06861842 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: CGIS-BIO-001-2019Actifarma
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Healthy Donors

Keywords

bioequivalence

Outcome Measures

Primary Outcomes (2)

• AUC

  concentration plasma under curve AUC

  0 hours - 72 hours

• Cmax

  peak concentration plasma Cmax

  0 hours - 6 hours

Secondary Outcomes (1)

• Tmax

  0 hours - 6 hours

Study Arms (2)

Period 1

ACTIVE COMPARATOR

Theralite® 300 mg

Drug: Theralite®; Drug: Actilitio®

Period 2

ACTIVE COMPARATOR

Actilitio® 300 mg

Drug: Theralite®; Drug: Actilitio®

Interventions

Theralite® DRUG

Reference

Also known as: lithium carbonate

Period 1; Period 2

Actilitio® DRUG

Test

Also known as: lithium carbonate

Period 1; Period 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Centro de Atencion e Investigacion Medica: lead

Study Sites (1)

Centro de Atención e Investigación Médica

Bogotá, Cundinamarca, 111156, Colombia

Location

MeSH Terms

Interventions

Lithium Carbonate

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 6, 2025
• Study Start: June 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: jul 2024 - abril 2025
• Access Criteria: indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed

Locations

CO (1)