Healthy, Healthy Donors
Conditions
Keywords
bioequivalence
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.
Interventions
DRUGTheralite®
Reference
DRUGActilitio®
Test
Sponsors
Centro de Atencion e Investigacion Medica
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 0 hours - 72 hours | concentration plasma under curve AUC |
| Cmax | 0 hours - 6 hours | peak concentration plasma Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 0 hours - 6 hours | Pharmacokinetic Outcome Measures |
Countries
Colombia
Outcome results
None listed