Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-31 @ 6:43 AM
Study NCT ID:
NCT02604004
Status:
COMPLETED
Last Update Posted:
2015-11-13
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D004341', 'term': 'Drug Evaluation'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': 'Up to 36 hours', 'description': 'Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma.'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to 36 hours', 'description': 'Maximum concentration (Cmax) of lamivudine in plasma.'}, {'measure': 'Tmax', 'timeFrame': 'Up to 36 hours', 'description': 'Time for Maximum concentration (Tmax) of lamivudine in plasma.'}, {'measure': 'T1/2', 'timeFrame': 'Up to 72 hours', 'description': 'Terminal half-time of lamivudine in plasma.'}, {'measure': 'AUCinf', 'timeFrame': 'Up to 36 hours', 'description': 'Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lamivudine', 'bioequivalence test', 'pharmacokinetics', 'high-performance liquid chromatography', '3TC', 'LC-MS/MS', 'mass spectrometry'], 'conditions': ['HIV INFECTIONS']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': "Goodman & Gilman's The Pharmacologic Basis of Therapeutics - 11th Ed. (2006)"}, {'type': 'RESULT', 'citation': 'Martindale The Complete Drug Reference - Thirty-sixth edition (2009).'}, {'type': 'RESULT', 'citation': 'http://www4.anvisa.gov.br/base/visadoc/BM/BM[25676-1-0].PDF acessado em 13/10/2011.'}, {'type': 'RESULT', 'citation': 'ANVISA. Manual de Boas Práticas em Biodisponibilidade/ Bioequivalência. Volume I. Agência Nacional de Vigilância Sanitária. Brasília: ANVISA, 2002.'}, {'type': 'RESULT', 'citation': 'ANVISA. Resolução RE nº 899, de 29 de maio de 2003. "Guia para validação de métodos analíticos e bioanalíticos". ANVISA-MS, Brasília.'}, {'type': 'RESULT', 'citation': 'ANVISA. Resolução RE nº 1170, de 19 de abril de 2006. "Guia para provas de biodisponibilidade relativa/ bioequivalência de medicamentos". ANVISA-MS, Brasília.'}, {'type': 'RESULT', 'citation': 'ANVISA. "Guia para planejamento e realização da etapa estatística de estudos de Biodisponibilidade relativa / Bioequivalência". RE Nº. 898, de 29 de maio de 2003.'}, {'pmid': '15907596', 'type': 'RESULT', 'citation': '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': '15793367', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '12537512', 'type': 'RESULT', 'citation': 'Schwartz JB. The influence of sex on pharmacokinetics. Clin Pharmacokinet. 2003;42(2):107-21. doi: 10.2165/00003088-200342020-00001.'}, {'pmid': '7227774', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '7452494', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '20114004', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '17707845', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '7769277', 'type': 'RESULT', 'citation': "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': '7751691', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '9989342', 'type': 'RESULT', 'citation': 'Johnson MA, Moore KH, Yuen GJ, Bye A, Pakes GE. Clinical pharmacokinetics of lamivudine. Clin Pharmacokinet. 1999 Jan;36(1):41-66. doi: 10.2165/00003088-199936010-00004.'}, {'pmid': '9098665', 'type': 'RESULT', 'citation': 'Perry CM, Faulds D. Lamivudine. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection. Drugs. 1997 Apr;53(4):657-80. doi: 10.2165/00003495-199753040-00008.'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Considered healthy after undergoing a clinical evaluation;\n* Agree freely and sign the Recruitment and Informed Consent Term, after all the content of the protocol was clear before any procedure;\n* Present the body mass index greater than 19 and less than 30.\n\nExclusion Criteria:\n\n* Results of laboratory tests outside the range considered normal, unless they were considered clinically irrelevant;\n* Allergic to lamivudine or any other drug;\n* Positive outcome of the pre-admission pregnancy test;\n* 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;\n* Use abusive alcoholic beverage;\n* Use of illicit drugs and tobacco;\n* 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;'}, 'identificationModule': {'nctId': 'NCT02604004', 'briefTitle': 'Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NUD_04_12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Period 1', 'description': 'Epivir ® tablet 150-mg single dose (drug reference)', 'interventionNames': ['Drug: Epivir ® tablet 150-mg single dose (drug reference)', 'Drug: Lamivudine 150-mg tablet single dose (drug test)']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2', 'description': 'Lamivudine 150-mg tablet single dose (drug test)', 'interventionNames': ['Drug: Epivir ® tablet 150-mg single dose (drug reference)', 'Drug: Lamivudine 150-mg tablet single dose (drug test)']}], 'interventions': [{'name': 'Epivir ® tablet 150-mg single dose (drug reference)', 'type': 'DRUG', 'otherNames': ['lamivudine', '3TC'], 'description': 'Bioequivalence lamivudine 150 mg tablets fasting condition', 'armGroupLabels': ['Period 1', 'Period 2']}, {'name': 'Lamivudine 150-mg tablet single dose (drug test)', 'type': 'DRUG', 'otherNames': ['3TC'], 'description': 'Bioequivalence lamivudine 150 mg tablets fasting condition', 'armGroupLabels': ['Period 1', 'Period 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'José Homero de Souza Filho', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}