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

NCT ID: NCT06861842

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Period 1

Theralite® 300 mg

Group Type: ACTIVE_COMPARATOR

Theralite®

Intervention Type: DRUG

Reference

Actilitio®

Intervention Type: DRUG

Test

Period 2

Actilitio® 300 mg

Group Type: ACTIVE_COMPARATOR

Theralite®

Intervention Type: DRUG

Reference

Actilitio®

Intervention Type: DRUG

Test

Interventions

Theralite®

Reference

Intervention Type: DRUG

Actilitio®

Test

Intervention Type: DRUG

Other Intervention Names

lithium carbonate; lithium carbonate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Atencion e Investigacion Medica

NETWORK

Sponsor Role: lead

Responsible Party

Humberto Reynales MD MSc PhD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Atención e Investigación Médica

Bogotá, Cundinamarca, Colombia

Countries

Colombia

Other Identifiers

Actifarma

Identifier Type: OTHER

Identifier Source: secondary_id

CGIS-BIO-001-2019

Identifier Type: -

Identifier Source: org_study_id