Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.

NCT02583464 | Completed Phase 1

• 1 other identifier: BE-TNF-EMT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration [Cmax]

  48 hours

• Area Under the Curve [AUC]

  48 hours

Secondary Outcomes (1)

• Adverse events

  48 hours

Study Arms (2)

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).

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).

Drug: Tenofovir disoproxil fumarate and emtricitabine

Interventions

Tenofovir disoproxil fumarate and emtricitabine DRUG

Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.

Reference-Test; Test-Reference

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead

Study Sites (1)

Laboratorio Elea SACIFyA

Capital Federal, Buenos Aires, C1417AZE, Argentina

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

HIV Infections; 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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Guillermo Di Girolamo, MD

  Centro de la Asociación Mutual de Profesionales del Hospital Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 22, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

AR (1)