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

NCT02604004 | Completed Phase 1 DMC

• 1 other identifier: NUD_04_12
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV INFECTIONS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• AUClast

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

  Up to 36 hours

Secondary Outcomes (4)

• Cmax

  Up to 36 hours

• Tmax

  Up to 36 hours

• T1/2

  Up to 72 hours

• AUCinf

  Up to 36 hours

Study Arms (2)

Period 1

ACTIVE COMPARATOR

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

Drug: Epivir ® tablet 150-mg single dose (drug reference); Drug: Lamivudine 150-mg tablet single dose (drug test)

Period 2

EXPERIMENTAL

Lamivudine 150-mg tablet single dose (drug test)

Drug: Epivir ® tablet 150-mg single dose (drug reference); Drug: Lamivudine 150-mg tablet single dose (drug test)

Interventions

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

Bioequivalence lamivudine 150 mg tablets fasting condition

Also known as: lamivudine, 3TC

Period 1; Period 2

Lamivudine 150-mg tablet single dose (drug test) DRUG

Bioequivalence lamivudine 150 mg tablets fasting condition

Also known as: 3TC

Period 1; Period 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Related Publications (22)

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

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

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

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

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

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• 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.

  PMID: 15907596 RESULT

• 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.

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• Pluda JM, Cooley TP, Montaner JS, Shay LE, Reinhalter NE, Warthan SN, Ruedy J, Hirst HM, Vicary CA, Quinn JB, et al. A phase I/II study of 2'-deoxy-3'-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection. J Infect Dis. 1995 Jun;171(6):1438-47. doi: 10.1093/infdis/171.6.1438.

  PMID: 7769277 RESULT

• van Leeuwen R, Katlama C, Kitchen V, Boucher CA, Tubiana R, McBride M, Ingrand D, Weber J, Hill A, McDade H, et al. Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a phase I/II study. J Infect Dis. 1995 May;171(5):1166-71. doi: 10.1093/infdis/171.5.1166.

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• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Lamivudine; Tablets; Drug Evaluation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Dosage Forms; Pharmaceutical Preparations; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 13, 2015
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 13, 2015

Record last verified: 2015-11