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)
Sponsored by
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
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
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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