Clinical trial NCT02604004: Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers
Official title: Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet 150 mg (Test) and EPIVIR of Glaxosmithkline in Healthy Volunteers of Both Genders in Fasting Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV INFECTIONS
Keywords: lamivudine
bioequivalence test
pharmacokinetics
high-performance liquid chromatography
3TC
LC-MS/MS
mass spectrometry
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres under fasting condition.

Detailed description: It is an open, randomized, crossover 2x2, single dose, with the administration of medicine with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14 females). Of the 28 volunteers planned in the study protocol to start, gave up one (woman) before the start of Phase I. So the study was initiated and completed with the participation of 27 volunteers. The volunteers were in hospital for a period of approximately 36 hours in each stage.

Eligibility criteria: Inclusion Criteria:

* Considered healthy after undergoing a clinical evaluation;
* Agree freely and sign the Recruitment and Informed Consent Term, after all the content of the protocol was clear before any procedure;
* Present the body mass index greater than 19 and less than 30.

Exclusion Criteria:

* Results of laboratory tests outside the range considered normal, unless they were considered clinically irrelevant;
* Allergic to lamivudine or any other drug;
* Positive outcome of the pre-admission pregnancy test;
* Regular medication within four (4) weeks prior to the start of the study or use of any medication to present interaction with lamivudine one week before the start of the study;
* Use abusive alcoholic beverage;
* Use of illicit drugs and tobacco;
* History of liver disease, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric; hypo- or hypertension of any cause that required pharmacological treatment; myocardial infarction, angina and / or heart failure;

Primary outcomes:
measure: AUClast
timeFrame: Up to 36 hours
Secondary outcomes:
measure: Cmax
timeFrame: Up to 36 hours
measure: Tmax
timeFrame: Up to 36 hours
measure: T1/2
timeFrame: Up to 72 hours
measure: AUCinf
timeFrame: Up to 36 hours
Other outcomes:
Locations:
Study officials:
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