HealthyPhase 4NCT06861842
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
A Phase 4 study testing Theralite® and Actilitio® in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica at 1 site in Colombia.
Trial summary
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Donors
- What is being tested?
- Theralite® and Actilitio®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2024to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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.
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- 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.
Who cannot join
- - 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.
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- 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 locations and contacts
1 site in 1 country.
Colombia1 site
Centro de Atención e Investigación Médica
Bogotá, Cundinamarca, 111156
About this study
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition
Read the 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
- Being tested
- Theralite®, Actilitio®
- Keywords
- bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theralite®Drug
Also called lithium carbonate
Reference
Actilitio®Drug
Also called lithium carbonate
Test
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Active comparator | Theralite® 300 mg Receives: Drug: Theralite®; Drug: Actilitio® |
| Period 2 | Active comparator | Actilitio® 300 mg Receives: Drug: Theralite®; Drug: Actilitio® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
concentration plasma under curve AUC
Measured: 0 hours - 72 hours
Cmax
peak concentration plasma Cmax
Measured: 0 hours - 6 hours
Secondary outcomes (1)
Tmax
Pharmacokinetic Outcome Measures
Measured: 0 hours - 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jun 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atencion e Investigacion Medica
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Humberto Reynales MD MSc PhD, Centro de Atencion e Investigacion Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861842
- Sponsor's protocol ID
- CGIS-BIO-001-2019
- Other IDs
- Actifarma
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06861842
- Acronym / sponsor ID
- CGIS-BIO-001-2019
- Conditions
- Healthy, Healthy Donors
- Keywords
- bioequivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centro de Atencion e Investigacion MedicaResearch network
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Active comparator | Drug: Theralite®, Drug: Actilitio®Theralite® 300 mg |
| Period 2 | Active comparator | Drug: Theralite®, Drug: Actilitio®Actilitio® 300 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- - 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)
Key exclusion criteria (13 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theralite®Also: lithium carbonateReference | Drug | Period 1, Period 2 |
| Actilitio®Also: lithium carbonateTest | Drug | Period 1, Period 2 |
Primary outcome
AUC
Time frame: 0 hours - 72 hours
concentration plasma under curve AUC
Cmax
Time frame: 0 hours - 6 hours
peak concentration plasma Cmax
1 secondary outcome
Tmax
Time frame: 0 hours - 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Theralite® and Actilitio® in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 0 hours - 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.