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

Centro de Atencion e Investigacion Medica

Status and phase: Active, not recruiting; Phase 4

Conditions: Healthy; Healthy Donors

Treatments: Drug: Theralite®; Drug: Actilitio®

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06861842

CGIS-BIO-001-2019

Actifarma (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Period 1

Active Comparator group

Description:

Theralite® 300 mg

Treatment:

Drug: Actilitio®

Drug: Theralite®

Period 2

Active Comparator group

Description:

Actilitio® 300 mg

Treatment:

Drug: Actilitio®

Drug: Theralite®