Clinical trial NCT06861842: Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
Official title: Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Healthy
Healthy Donors
Keywords: bioequivalence
Lead sponsor: Centro de Atencion e Investigacion Medica
Sponsor class: NETWORK
First posted: 2025-03-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: AUC
timeFrame: 0 hours - 72 hours
measure: Cmax
timeFrame: 0 hours - 6 hours
Secondary outcomes:
measure: Tmax
timeFrame: 0 hours - 6 hours
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Centro de Atención e Investigación Médica
state: Cundinamarca
Study officials:
References: