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

November 10, 2015 updated by: José Homero de Souza Filho, Universidade Federal de Pernambuco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUD_04_12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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