Acquired Immunodeficiency SyndromePhase 1NCT02583464
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
A Phase 1 study testing Tenofovir disoproxil fumarate and emtricitabine in people with Acquired Immunodeficiency Syndrome, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial summary
Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Tenofovir disoproxil fumarate and emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes between 21 and 55 years.
- Subjects with body mass index (BMI) between 19 and 27 kg / m².
- Subjects whose complementary tests (ECG, blood and urine) are within normal and / or clinically insignificant according to the judgment of the investigator. Women of childbearing age should have a negative pregnancy test and use a reliable method of contraception during the study (IUD or condoms)
- Subjects with systolic blood pressure between 110 mmHg and 139 mmHg; diastolic pressure between 70 mmHg and 89 mmHg; heart rate between 50 and 90 beats per minute.
- Subjects who signed informed consent.
Who cannot join
- Background of clinically significant allergies (except untreated asymptomatic seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component of the formulations studied.
- Drop of more than 20 mmHg in systolic blood pressure or more than 10 mmHg diastolic pressure in the first 3 minutes of postural change.
- Active smoker more than 10 cigarettes / day.
- Pregnant or lactating women.
- Current clinical evidence of severe digestive disorders, surgery of the digestive tract (except appendectomy).
- Current clinical evidence of kidney disease.
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- Current evidence of liver disorders
- Current clinical evidence of respiratory and heart diseases.
- The presence of diabetes mellitus, thyroid dysfunction or other endocrine disorder.
- Evidence of gastroduodenal disease.
- Current presence of any malignancy.
- History of abuse or addiction to drugs or alcohol during the past three years.
- Participation in a clinical trial within the last three months.
- Use of any drug within fourteen days before the start of the study.
- Subject donated or suffered blood loss during the last twelve weeks before the start of the study, or intends to donate blood within three months of the completion of the study.
- Excessive drinking of tea, cocoa, mate, coffee and / or beverages containing caffeine (> 5 cups / day) or wine (> 0.5 L / day) or alcohol (> 50 ml / day).
- ECG abnormalities.
- Positive serology for HIV, hepatitis B or hepatitis C.
- Women who are not using effective contraception (IUD, condom)
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Laboratorio Elea SACIFyA
Capital Federal, Buenos Aires, C1417AZE
About this study
Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
Read the detailed description
A randomized-sequence, open-label, two-period crossover study was conducted on 24 healthy Caucasian volunteers in a fasting state. A single oral dose of either T or R formulations was followed by a 7-day washout period. Blood samples were collected at baseline and 0.25, 0.50, 0.75, 1, 1.25, 1.5 2, 2.5, 3, 4, 7, 12, 24 and 48 h after administration. Emtricitabine and tenofovir concentrations were determined using a validated LC (liquid chromatography) - MS (mass spectrometry) / MS method. Adverse events were monitored based on clinical parameters and volunteer reports.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Tenofovir disoproxil fumarate and emtricitabine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarate and emtricitabineDrug
Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
| Study group | Role | What they receive |
|---|---|---|
| Test-Reference | Experimental | A new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) followed by a branded formulation (R). Receives: Drug: Tenofovir disoproxil fumarate and emtricitabine |
| Reference-Test | Experimental | A branded formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (R) followed by a new formulation (T). Receives: Drug: Tenofovir disoproxil fumarate and emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
Measured: 48 hours
Area Under the Curve [AUC]
Measured: 48 hours
Secondary outcomes (1)
Adverse events
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillermo Di Girolamo, MD, Principal investigator, Centro de la Asociación Mutual de Profesionales del Hospital Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583464
- Sponsor's protocol ID
- BE-TNF-EMT
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
- ClinicalTrials.gov ID
- NCT02583464
- Acronym / sponsor ID
- BE-TNF-EMT
- Conditions
- Acquired Immunodeficiency Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Oct 2015 (estimated)
- 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.
Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
Detailed description
A randomized-sequence, open-label, two-period crossover study was conducted on 24 healthy Caucasian volunteers in a fasting state. A single oral dose of either T or R formulations was followed by a 7-day washout period. Blood samples were collected at baseline and 0.25, 0.50, 0.75, 1, 1.25, 1.5 2, 2.5, 3, 4, 7, 12, 24 and 48 h after administration. Emtricitabine and tenofovir concentrations were determined using a validated LC (liquid chromatography) - MS (mass spectrometry) / MS method. Adverse events were monitored based on clinical parameters and volunteer reports.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test-Reference | Experimental | Drug: Tenofovir disoproxil fumarate and emtricitabineA new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) followed by a branded formulation (R). |
| Reference-Test | Experimental | Drug: Tenofovir disoproxil fumarate and emtricitabineA branded formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (R) followed by a new formulation (T). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects of both sexes between 21 and 55 years.
- Subjects with body mass index (BMI) between 19 and 27 kg / m².
- Subjects whose complementary tests (ECG, blood and urine) are within normal and / or clinically insignificant according to the judgment of the investigator. Women of childbearing age should have a negative pregnancy test and use a reliable method of contraception during the study (IUD or condoms)
- Subjects with systolic blood pressure between 110 mmHg and 139 mmHg; diastolic pressure between 70 mmHg and 89 mmHg; heart rate between 50 and 90 beats per minute.
- Subjects who signed informed consent.
Key exclusion criteria (19 listed)
- Background of clinically significant allergies (except untreated asymptomatic seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component of the formulations studied.
- Drop of more than 20 mmHg in systolic blood pressure or more than 10 mmHg diastolic pressure in the first 3 minutes of postural change.
- Active smoker more than 10 cigarettes / day.
- Pregnant or lactating women.
- Current clinical evidence of severe digestive disorders, surgery of the digestive tract (except appendectomy).
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 |
|---|---|---|
| Tenofovir disoproxil fumarate and emtricitabineTwo period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg. | Drug | Reference-Test, Test-Reference |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: 48 hours
Area Under the Curve [AUC]
Time frame: 48 hours
1 secondary outcome
Adverse events
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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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.
Guillermo Di Girolamo, MD principal investigator
Centro de la Asociación Mutual de Profesionales del Hospital Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir disoproxil fumarate and emtricitabine in people with Acquired Immunodeficiency Syndrome, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
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 5 inclusion and 19 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: finished, as of the sponsor's last update on 22 Oct 2015. 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 Argentina. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Plasma Concentration [Cmax] (time frame: 48 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 22 Oct 2015.