Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
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ClinicalTrials.gov Identifier: NCT02583464 |
Recruitment Status :
Completed
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
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Condition or disease | Intervention/treatment | Phase |
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Acquired Immunodeficiency Syndrome | Drug: Tenofovir disoproxil fumarate and emtricitabine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | December 2014 |

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).
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Drug: Tenofovir disoproxil fumarate and emtricitabine
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).
|
Drug: Tenofovir disoproxil fumarate and emtricitabine
Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg. |
- Maximum Plasma Concentration [Cmax] [ Time Frame: 48 hours ]
- Area Under the Curve [AUC] [ Time Frame: 48 hours ]
- Adverse events [ Time Frame: 48 hours ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583464
Argentina | |
Laboratorio Elea SACIFyA | |
Capital Federal, Buenos Aires, Argentina, C1417AZE |
Principal Investigator: | Guillermo Di Girolamo, MD | Centro de la Asociación Mutual de Profesionales del Hospital Italiano |
Responsible Party: | Laboratorio Elea Phoenix S.A. |
ClinicalTrials.gov Identifier: | NCT02583464 |
Other Study ID Numbers: |
BE-TNF-EMT |
First Posted: | October 22, 2015 Key Record Dates |
Last Update Posted: | October 22, 2015 |
Last Verified: | October 2015 |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Slow Virus Diseases Tenofovir Emtricitabine Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |