- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02583464
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
October 20, 2015 updated by: Laboratorio Elea Phoenix S.A.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Buenos Aires
-
Capital Federal, Buenos Aires, Argentina, C1417AZE
- Laboratorio Elea SACIFyA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test-Reference
A new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) followed by a branded formulation (R).
|
Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
|
Experimental: Reference-Test
A branded formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (R) followed by a new formulation (T).
|
Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Plasma Concentration [Cmax]
Time Frame: 48 hours
|
48 hours
|
Area Under the Curve [AUC]
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guillermo Di Girolamo, MD, Centro de la Asociación Mutual de Profesionales del Hospital Italiano
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
October 19, 2015
First Submitted That Met QC Criteria
October 20, 2015
First Posted (Estimate)
October 22, 2015
Study Record Updates
Last Update Posted (Estimate)
October 22, 2015
Last Update Submitted That Met QC Criteria
October 20, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
Other Study ID Numbers
- BE-TNF-EMT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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