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AzTrials

HIV INFECTIONSPhase 1NCT02604004

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

A Phase 1 study testing Epivir ® tablet 150-mg single dose (drug reference) and Lamivudine 150-mg tablet single dose (drug test) in people with HIV INFECTIONS, run by Universidade Federal de Pernambuco.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV INFECTIONS
What is being tested?
Epivir ® tablet 150-mg single dose (drug reference) and Lamivudine 150-mg tablet single dose (drug test)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
Apr 2013to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

About this study

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

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.

Read the 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.

Conditions
HIV INFECTIONS
Being tested
Epivir ® tablet 150-mg single dose (drug reference), Lamivudine 150-mg tablet single dose (drug test)
Keywords
lamivudine, bioequivalence test, pharmacokinetics, high-performance liquid chromatography, 3TC, LC-MS/MS, mass spectrometry
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called lamivudine, 3TC

    Bioequivalence lamivudine 150 mg tablets fasting condition

  • Lamivudine 150-mg tablet single dose (drug test)Drug

    Also called 3TC

    Bioequivalence lamivudine 150 mg tablets fasting condition

Study groups in NCT02604004
Study groupRoleWhat they receive
Period 1Active comparatorEpivir ® tablet 150-mg single dose (drug reference)
Receives: Drug: Epivir ® tablet 150-mg single dose (drug reference); Drug: Lamivudine 150-mg tablet single dose (drug test)
Period 2ExperimentalLamivudine 150-mg tablet single dose (drug test)
Receives: Drug: Epivir ® tablet 150-mg single dose (drug reference); Drug: Lamivudine 150-mg tablet single dose (drug test)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUClast

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

    Measured: Up to 36 hours

Secondary outcomes (4)

  1. Cmax

    Maximum concentration (Cmax) of lamivudine in plasma.

    Measured: Up to 36 hours

  2. Tmax

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

    Measured: Up to 36 hours

  3. T1/2

    Terminal half-time of lamivudine in plasma.

    Measured: Up to 72 hours

  4. AUCinf

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

    Measured: Up to 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02604004
Sponsor's protocol ID
NUD_04_12
Status last verified
Nov 2015
First submitted
5 Nov 2015
Last updated
13 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Goodman & Gilman's The Pharmacologic Basis of Therapeutics - 11th Ed. (2006)

  • Martindale The Complete Drug Reference - Thirty-sixth edition (2009).

  • http://www4.anvisa.gov.br/base/visadoc/BM/BM[25676-1-0].PDF acessado em 13/10/2011.

  • ANVISA. Manual de Boas Práticas em Biodisponibilidade/ Bioequivalência. Volume I. Agência Nacional de Vigilância Sanitária. Brasília: ANVISA, 2002.

  • ANVISA. Resolução RE nº 899, de 29 de maio de 2003. "Guia para validação de métodos analíticos e bioanalíticos". ANVISA-MS, Brasília.

  • ANVISA. Resolução RE nº 1170, de 19 de abril de 2006. "Guia para provas de biodisponibilidade relativa/ bioequivalência de medicamentos". ANVISA-MS, Brasília.

  • ANVISA. "Guia para planejamento e realização da etapa estatística de estudos de Biodisponibilidade relativa / Bioequivalência". RE Nº. 898, de 29 de maio de 2003.

  • Kano EK, dos Reis Serra CH, Koono EE, Andrade SS, Porta V. Determination of lamivudine in human plasma by HPLC and its use in bioequivalence studies. Int J Pharm. 2005 Jun 13;297(1-2):73-9. doi: 10.1016/j.ijpharm.2005.03.002. Epub 2005 Apr 26.

    PubMed 15907596

  • Narang VS, Lulla A, Malhotra G, Purandare S. Pharmacokinetic profiling and bioequivalence evaluation of 2 lamivudine tablet formulations after single oral administration in healthy human Indian volunteers. J Acquir Immune Defic Syndr. 2005 Apr 15;38(5):566-9. doi: 10.1097/01.qai.0000155202.51232.f5.

    PubMed 15793367

  • Schwartz JB. The influence of sex on pharmacokinetics. Clin Pharmacokinet. 2003;42(2):107-21. doi: 10.2165/00003088-200342020-00001.

    PubMed 12537512

  • Wald A, Van Thiel DH, Hoechstetter L, Gavaler JS, Egler KM, Verm R, Scott L, Lester R. Gastrointestinal transit: the effect of the menstrual cycle. Gastroenterology. 1981 Jun;80(6):1497-500.

    PubMed 7227774

  • Greenblatt DJ, Divoll M, Harmatz JS, Shader RI. Oxazepam kinetics: effects of age and sex. J Pharmacol Exp Ther. 1980 Oct;215(1):86-91.

    PubMed 7452494

  • FLOCKHART D. A. Drug interactions: Cytochrome P450 drug interaction table. Indiana School of Medicine. 2007. http://medicine.iupui.edu/clinpharm/ddis/ table.asp. Accessed December 1, 2009.

  • Bigos KL, Pollock BG, Stankevich BA, Bies RR. Sex differences in the pharmacokinetics and pharmacodynamics of antidepressants: an updated review. Gend Med. 2009 Dec;6(4):522-43. doi: 10.1016/j.genm.2009.12.004.

    PubMed 20114004

  • Ofotokun I, Chuck SK, Hitti JE. Antiretroviral pharmacokinetic profile: a review of sex differences. Gend Med. 2007 Jun;4(2):106-19. doi: 10.1016/s1550-8579(07)80025-8.

    PubMed 17707845

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epivir ® tablet 150-mg single dose (drug reference) and Lamivudine 150-mg tablet single dose (drug test) in people with HIV INFECTIONS, run by Universidade Federal de Pernambuco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast (time frame: Up to 36 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02604004, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.

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