Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02604004
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
José Homero de Souza Filho, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
HIV INFECTIONS Drug: Epivir ® tablet 150-mg single dose (drug reference) Drug: Lamivudine 150-mg tablet single dose (drug test) Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

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:
  • lamivudine
  • 3TC

Drug: Lamivudine 150-mg tablet single dose (drug test)
Bioequivalence lamivudine 150 mg tablets fasting condition
Other Name: 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:
  • lamivudine
  • 3TC

Drug: Lamivudine 150-mg tablet single dose (drug test)
Bioequivalence lamivudine 150 mg tablets fasting condition
Other Name: 3TC




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Up to 36 hours ]
    Maximum concentration (Cmax) of lamivudine in plasma.

  2. Tmax [ Time Frame: Up to 36 hours ]
    Time for Maximum concentration (Tmax) of lamivudine in plasma.

  3. T1/2 [ Time Frame: Up to 72 hours ]
    Terminal half-time of lamivudine in plasma.

  4. AUCinf [ Time Frame: Up to 36 hours ]
    Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Publications of Results:
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.
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.
World Medical Association Declaration of Helsinki (WMA). Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 7, 2000 [WMA Web site]. http://www.wma.net/e/policy/b3.htm . Accessed December 20, 2009
Center for Drug Evaluation and Research, US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations [COER Web site). http://www.fda.gov/cder/guidance/5356ful.pdf. Accessed February 22, 2010.
EMEA (European Agency for the Evaluation of Medicinal Products). CPMP (Committee for Propietary Medicinal Products). Note for guidance on the investigation of bioavailability and bioequivalence. London, July 2001.

Layout table for additonal information
Responsible Party: José Homero de Souza Filho, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02604004     History of Changes
Other Study ID Numbers: NUD_04_12
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by José Homero de Souza Filho, Universidade Federal de Pernambuco:
lamivudine
bioequivalence test
pharmacokinetics
high-performance liquid chromatography
3TC
LC-MS/MS
mass spectrometry

Additional relevant MeSH terms:
Layout table for MeSH terms
Lamivudine
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents