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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03309566
Other study ID # PRO-BEQ-EET-002-V.01
Secondary ID
Status Completed
Phase Phase 4
First received October 10, 2017
Last updated October 12, 2017
Start date September 4, 2016
Est. completion date February 28, 2017

Study information

Verified date October 2017
Source Laboratorio Elea S.A.C.I.F. y A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 28, 2017
Est. primary completion date February 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Argentina DominguezLab Paraná Entre Ríos

Sponsors (1)

Lead Sponsor Collaborator
Laboratorio Elea S.A.C.I.F. y A.

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax Maximum plasma concentration 192 hours
Primary AUC Area under the curve 192 hours
Secondary Adverse events Drug related toxicity 192 hours
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