HealthyPhase 4EltrombopagNCT06834451
Bioequivalence Study of Revolade® Eltrombopag 50 mg
A Phase 4 study testing Revolade® and Eltrombopag (EPAG) in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica at 1 site in Colombia.
Trial summary
Bioequivalence Study 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?
- Revolade® and Eltrombopag (EPAG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2025to 30 Oct 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
- Women and men between 18 and 50 years of age. Have been clinically diagnosed as healthy by the trial physician. Subjects with clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical screening. Current for 3 months.
- Subjects non-smokers for the last 3 months. Having signed the informed consent. Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.
- Body mass index between 18-30 kg/m2 at the time of inclusion in the study. Subject with complete contact information (cell phone and/or landline contact, address, email).
- 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.
Who cannot join
- Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.
- Woman in a state of pregnancy or breastfeeding. Subject diagnosed with hematological disorders, such as anemias and/or polycythemia.
- Subjects with a history of gastric surgeries. Permanent or temporary use during the last 15 days of any type of medication either on their own initiative or by medical prescription. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of the present trial.
- Consumption of xanthines from coffee, tea or chocolate during the 48 hours prior to hospitalization.
- Drinking alcohol in excess of 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days prior to hospitalization.
- Consumption of drugs of abuse or psychoactive substances reported as positive test at the time of hospitalization.
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- Known hypersensitivity to the active ingredient or excipients of the test product.
- Medical history of angioedema or anaphylaxis. 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 time of signing the informed consent.
- Having donated blood in the 30 days prior to the time of signing the informed consent.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Centro de Atención e Investigación Médica
Chía, Cundinamarca, 111156
About this study
Official title: Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition
Bioequivalence Study
Read the detailed description
A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design:
Open-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose
- Conditions
- Healthy, Healthy Donors
- Being tested
- Revolade®, Eltrombopag (EPAG)
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revolade®Drug
Also called Eltrombopag
Tableta 50 mg Reference
Eltrombopag (EPAG)Drug
Tableta 50 mg
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Active comparator | Revolade® Reference Receives: Drug: Revolade®; Drug: Eltrombopag (EPAG) |
| Period 2 | Active comparator | Eltrombopag TEST Receives: Drug: Revolade®; Drug: Eltrombopag (EPAG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Outcome Measures
Peak Plasma Concentration (Cmax)
Measured: 0- 6 hours
Pharmacokinetic Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Measured: 0 - 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jun 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Bioequivalence study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- NCT06834451
- Sponsor's protocol ID
- ELTROM-BIO-001-2023
- Acronym
- Eltrombopag
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2025
- Last updated
- 19 Jun 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06834451
- Acronym / sponsor ID
- Eltrombopag / ELTROM-BIO-001-2023
- Conditions
- Healthy, Healthy Donors
- Keywords
- Bioequivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centro de Atencion e Investigacion MedicaResearch network
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 19 Feb 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.
Bioequivalence Study
Detailed description
A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design:
Open-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Active comparator | Drug: Revolade®, Drug: Eltrombopag (EPAG)Revolade® Reference |
| Period 2 | Active comparator | Drug: Revolade®, Drug: Eltrombopag (EPAG)Eltrombopag TEST |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women and men between 18 and 50 years of age. Have been clinically diagnosed as healthy by the trial physician. Subjects with clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical screening. Current for 3 months.
- Subjects non-smokers for the last 3 months. Having signed the informed consent. Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.
- Body mass index between 18-30 kg/m2 at the time of inclusion in the study. Subject with complete contact information (cell phone and/or landline contact, address, email).
- 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.
Key exclusion criteria (10 listed)
- Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.
- Woman in a state of pregnancy or breastfeeding. Subject diagnosed with hematological disorders, such as anemias and/or polycythemia.
- Subjects with a history of gastric surgeries. Permanent or temporary use during the last 15 days of any type of medication either on their own initiative or by medical prescription. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of the present trial.
- Consumption of xanthines from coffee, tea or chocolate during the 48 hours prior to hospitalization.
- Drinking alcohol in excess of 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days prior to hospitalization.
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 |
|---|---|---|
| Revolade®Also: EltrombopagTableta 50 mg Reference | Drug | Period 1, Period 2 |
| Eltrombopag (EPAG)Tableta 50 mg | Drug | Period 1, Period 2 |
Primary outcome
Pharmacokinetic Outcome Measures
Time frame: 0- 6 hours
Peak Plasma Concentration (Cmax)
Pharmacokinetic Outcome Measures
Time frame: 0 - 6 hours
Area under the plasma concentration versus time curve (AUC)
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 19 Jun 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 Revolade® and Eltrombopag (EPAG) 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 4 inclusion and 10 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 19 Jun 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?
Pharmacokinetic Outcome Measures (time frame: 0- 6 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 19 Jun 2025.