Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers

Study Overview
=================
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.

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

Conditions
-----------------
HIV INFECTIONS

Intervention / Treatment
-----------------
* Drug: Epivir ® tablet 150-mg single dose (drug reference)
* Drug: Lamivudine 150-mg tablet single dose (drug test)


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Period 1<br>Epivir ® tablet 150-mg single dose (drug reference) | Drug: Epivir ® tablet 150-mg single dose (drug reference)<br>* Bioequivalence lamivudine 150 mg tablets fasting condition<br>* Other names: 3TC;Drug: Lamivudine 150-mg tablet single dose (drug test)<br>* Bioequivalence lamivudine 150 mg tablets fasting condition<br>* Other names: 3TC;|
| Experimental: Period 2<br>Lamivudine 150-mg tablet single dose (drug test) | Drug: Epivir ® tablet 150-mg single dose (drug reference)<br>* Bioequivalence lamivudine 150 mg tablets fasting condition<br>* Other names: 3TC;Drug: Lamivudine 150-mg tablet single dose (drug test)<br>* Bioequivalence lamivudine 150 mg tablets fasting condition<br>* Other names: 3TC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma. | Up to 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration (Cmax) of lamivudine in plasma. | Up to 36 hours | 
| Tmax | Time for Maximum concentration (Tmax) of lamivudine in plasma. | Up to 36 hours | 
| T1/2 | Terminal half-time of lamivudine in plasma. | Up to 72 hours | 
| AUCinf | Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma. | Up to 36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lamivudine, bioequivalence test, pharmacokinetics, high-performance liquid chromatography, 3TC, LC-MS/MS, mass spectrometry