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

Primary Purpose

HIV INFECTIONS

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Epivir ® tablet 150-mg single dose (drug reference)

Lamivudine 150-mg tablet single dose (drug test)

About this trial

This is an interventional basic science trial for HIV INFECTIONS focused on measuring lamivudine, bioequivalence test, pharmacokinetics, high-performance liquid chromatography, 3TC, LC-MS/MS, mass spectrometry

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Period 1

Period 2

Arm Description

Epivir ® tablet 150-mg single dose (drug reference)

Lamivudine 150-mg tablet single dose (drug test)

Outcomes

Primary Outcome Measures

AUClast

Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma.

Secondary Outcome Measures

Cmax

Maximum concentration (Cmax) of lamivudine in plasma.

Tmax

Time for Maximum concentration (Tmax) of lamivudine in plasma.

T1/2

Terminal half-time of lamivudine in plasma.

AUCinf

Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma.

Full Information

NCT ID

NCT02604004

First Posted

November 5, 2015

Last Updated

November 10, 2015

Sponsor

Universidade Federal de Pernambuco

1. Study Identification

Unique Protocol Identification Number

NCT02604004

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV INFECTIONS

Keywords

lamivudine, bioequivalence test, pharmacokinetics, high-performance liquid chromatography, 3TC, LC-MS/MS, mass spectrometry

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Period 1

Arm Type

Active Comparator

Arm Description

Epivir ® tablet 150-mg single dose (drug reference)

Arm Title

Period 2

Arm Type

Experimental

Arm Description

Lamivudine 150-mg tablet single dose (drug test)

Intervention Type

Drug

Intervention Name(s)

Epivir ® tablet 150-mg single dose (drug reference)

Other Intervention Name(s)

lamivudine, 3TC

Intervention Description

Bioequivalence lamivudine 150 mg tablets fasting condition

Intervention Type

Drug

Intervention Name(s)

Lamivudine 150-mg tablet single dose (drug test)

Other Intervention Name(s)

3TC

Intervention Description

Bioequivalence lamivudine 150 mg tablets fasting condition

Primary Outcome Measure Information:

Title

AUClast

Description

Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma.

Time Frame

Up to 36 hours

Secondary Outcome Measure Information:

Title

Cmax

Description

Maximum concentration (Cmax) of lamivudine in plasma.

Time Frame

Up to 36 hours

Title

Tmax

Description

Time for Maximum concentration (Tmax) of lamivudine in plasma.

Time Frame

Up to 36 hours

Title

T1/2

Description

Terminal half-time of lamivudine in plasma.

Time Frame

Up to 72 hours

Title

AUCinf

Description

Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma.

Time Frame

Up to 36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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;

12. IPD Sharing Statement

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

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