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Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir

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ClinicalTrials.gov Identifier: NCT03309566
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.

Brief Summary:
Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.

Condition or disease Intervention/treatment Phase
Healthy Drug: Efavirenz, tenofovir disoproxil fumarate and emtricitabine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-dose, two-way crossover.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bioequivalence Study of Efavirenz, Emtricitabine and Tenofovir in Healthy Volunteers, After Administering a Single Dose of a Fixed Dose Combination of the Test Formulation With Respect to the Reference Product, Atripla ® From Gador S.A
Actual Study Start Date : September 4, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017


Arm Intervention/treatment
Experimental: Test - Reference
A new formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) followed by a branded formulation (R).
Drug: Efavirenz, tenofovir disoproxil fumarate and emtricitabine
Two period administration of a formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.

Experimental: Reference - Test
A branded formulation (R) followed by a new formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T).
Drug: Efavirenz, tenofovir disoproxil fumarate and emtricitabine
Two period administration of a formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.




Primary Outcome Measures :
  1. Cmax [ Time Frame: 192 hours ]
    Maximum plasma concentration

  2. AUC [ Time Frame: 192 hours ]
    Area under the curve


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 192 hours ]
    Drug related toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male subjects between 18 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.

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.


Information from the National Library of Medicine

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): NCT03309566


Locations
Argentina
DominguezLab
Paraná, Entre Ríos, Argentina, 3102
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.
Investigators
Principal Investigator: María C Fritz, MD DominguezLab

Responsible Party: Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier: NCT03309566     History of Changes
Other Study ID Numbers: PRO-BEQ-EET-002-V.01
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Efavirenz
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers