Delving into the Latest Updates on Lamivudine/Zidovudine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Lamivudine/zidovudine (Mylan Pharmaceuticals), Lamuzid, Zidovudine and Lamivudine

+ [7]

Target

RT

Action

inhibitors

Mechanism

RT inhibitors(Viral reverse transcriptase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication-

Originator Organization

Active Organization

Inactive Organization

ViiV Healthcare Co.Pharmacare Ltd.Teva Pharmaceuticals Europe BV

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (26 Sep 1997),

HIV Infections

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC10H13N5O4

InChIKeyHBOMLICNUCNMMY-XLPZGREQSA-N

CAS Registry30516-87-1

View All Structures (3)

主要研究目的：按有关生物等效性试验的规定，选择生产商为GlaxoSmithKline的齐多拉米双夫定片（商品名：Combivir®，规格：每片含齐多夫定300mg和拉米夫定150mg）为参比制剂，对安徽贝克生物制药有限公司生产并提供的受试制剂齐多拉米双夫定片（规格：每片含齐多夫定300mg和拉米夫定150mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂齐多拉米双夫定片（规格：每片含齐多夫定300mg和拉米夫定150mg）和参比制剂齐多拉米双夫定片（商品名：Combivir®，规格：每片含齐多夫定300mg和拉米夫定150mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the zidovudine tablets (trade name: Combivir®, specification: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine) produced by GlaxoSmithKline were selected as the reference preparation, and the test preparation zidovudine tablets (specification: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine) produced and provided by Anhui Baker Biopharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation Zidovudine Tablets (specification: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine) and the reference preparation Zidovudine Tablets (trade name: Combivir®, specification: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine) to healthy volunteers.

Start Date04 Nov 2022

Sponsor / Collaborator

Anhui Baker Biopharmaceutical Co., Ltd.

CTR20192017

/ CompletedNot Applicable

齐多拉米双夫定片在中国健康受试者单次、空腹及餐后、随机开放、两制剂、三周期三序列三交叉生物等效性试验

[Translation] A single-dose, fasting and postprandial, randomized, open-label, two-dose, three-period, three-sequence, three-crossover bioequivalence study of zidovudine tablets in healthy Chinese subjects

评价东北制药集团沈阳第一制药有限公司生产的齐多拉米双夫定片（规格：每片含齐多夫定300mg和拉米夫定150mg）与葛兰素史克制药公司生产的齐多拉米双夫定片（商品名：双汰芝®，规格：每片含齐多夫定300mg和拉米夫定150mg）的生物等效性。通过不良事件发生率、实验室检验结果、生命体征和体格检查的变化情况评估齐多拉米双夫定片安全性。

[Translation]

Evaluate the difference between Zidovudine tablets produced by Shenyang First Pharmaceutical Co., Ltd. of the Northeast Pharmaceutical Group (specifications: each tablet contains 300 mg of Zidovudine and 150 mg of Lamivudine) and Zidovudine produced by GlaxoSmithKline Pharmaceutical Company. Bioequivalence of Mildoudine Tablets (trade name: Shuangtaizhi®, specifications: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine). The safety of Zidoramibivudine Tablets was evaluated through the incidence of adverse events, laboratory test results, changes in vital signs and physical examination.

Start Date03 Nov 2019

Sponsor / Collaborator

Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.

CTR20190551

/ SuspendedNot Applicable

齐多拉米双夫定片在中国健康受试者中随机、开放、空腹及餐后、单剂量、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of zidovudine tablets in healthy Chinese subjects

比较受试制剂中药物的吸收程度和吸收速度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹及餐后给药条件下的生物等效性。观察健康志愿受试者口服受试制剂齐多拉米双夫定片（规格：每片含拉米夫定150mg和齐多夫定300mg）和参比制剂齐多拉米双夫定片（商品名：双汰芝®，规格：每片含拉米夫定150mg和齐多夫定300mg）的安全性。

[Translation]

Compare whether the absorption degree and absorption rate of the drug in the test preparation are within the acceptable range with the reference preparation, and compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Observe the safety of healthy volunteers taking the test preparation Zidovudine Tablets (Specifications: Each tablet contains 150 mg of lamivudine and 300 mg of zidovudine) and the reference preparation Zidovudine Tablets (trade name: Shuangtaizhi®, specifications: Each tablet contains 150 mg of lamivudine and 300 mg of zidovudine).

Start Date19 Apr 2019

Sponsor / Collaborator

Anhui Baker Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Lamivudine/Zidovudine

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100 Translational Medicine associated with Lamivudine/Zidovudine

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100 Patents (Medical) associated with Lamivudine/Zidovudine

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246

Literatures (Medical) associated with Lamivudine/Zidovudine

18 Nov 2022·ChemistrySelect

Using Both Classical and Chemometric Chromatographic Measurements to Quantify and Monitor the in‐vitro Dissolution Profiles of Lamivudine and Zidovudine in Combined Tablets

Author: Rouhani, Ghazal ; Tilkan, M. Günseli ; Büker, Eda ; Hoang, Vu Dang ; Özdemir, Nurten ; Dinç, Erdal

AbstractClassical and chemometric calibration strategies based‐Ultra Performance Liquid Chromatography‐Photodiode Array (UPLC‐PDA) measurements were improved to monitor the in‐vitro dissolution profiles of lamivudine (LAM) and zidovudine (ZID) in tablets and to quantify drugs. To generate UPLC‐PDA data, UPLC analysis was done using the mobile phase containing acetonitrile‐acetate buffer pH 5.0 (18 : 82, v/v). In the classical strategy, calibration curves were obtained by using the peak area ratios detected at 274 nm for LAM and 268 nm for ZID, respectively. Principal component regression (PCR) and partial least squares (PLS) strategies were used to solve the same problem using UPLC‐PDA measurements obtained at eight different wavelengths. Both classical and chemometric approaches were successfully applied for drugs assay and in‐vitro dissolution testing. Assay results showed that the proposed chemometric tools gave better results because they helped to minimize the effect of chromatographic issues that commonly occur with the classical UPLC approach, such as the higher standard deviation of the assay results.

29 Oct 2019·mBio

CD161 ⁺ CD4 ⁺ T Cells Harbor Clonally Expanded Replication-Competent HIV-1 in Antiretroviral Therapy-Suppressed Individuals

Article

Author: Li, Xiaomin ; Zhao, Jiacong ; Deng, Kai ; Cai, Weiping ; Li, Qijuan ; Liu, Zhaoli ; Hu, Ronglin ; Gao, Hongbo ; Zhao, Lu ; Huang, Zhuoqiong ; Li, Linghua ; Yang, Yanyan

The latent reservoir continues to be the major obstacle to curing HIV-1 infection. The clonal expansion of latently infected cells adds another layer maintaining the long-term stability of the reservoir, but its mechanism remains unclear. Here, we report that CD161 + CD4 + T cells serve as an important compartment of the HIV-1 latent reservoir and contain a significant amount of clonally expanded proviruses. In our study, we describe a feasible strategy that may reduce the size of the latent reservoir to a certain extent by counterbalancing the repopulation and dissemination of latently infected cells.

01 Apr 2019·Antiviral TherapyQ4 · MEDICINE

Therapeutic drug Monitoring of Darunavir/Ritonavir in Pregnancy

Q4 · MEDICINE

Article

Author: Murtagh, Ross ; Lawler, Marguerite ; Lambert, John S ; Redmond, Niamh ; Le Blanc, David ; Khoo, Saye H ; McDonald, Grainne ; Jackson, Valerie ; Else, Laura J ; Kuan, Kenneth BK ; Avramovic, Gordana ; Patel, Anjali

Background Physiological changes during pregnancy can have a significant impact on antiretroviral pharmacokinetics (PK), which may result in reduced drug efficacy. Here we describe the PK of darunavir/ritonavir (DRV/r) 800/100 once daily in a cohort of pregnant women undergoing routine therapeutic drug monitoring (TDM) as well as transplacental passage of DRV by measuring and comparing cord blood and maternal blood samples at delivery. Methods Pregnant HIV-positive women received DRV/r as part of routine pre-natal care. Demographic and clinical data were collected. DRV plasma concentrations [DRV] were determined in the first (T1), second (T2) and third (T3) trimester and at postpartum (PP). The target concentration was 550 ng/ml. Where possible, paired maternal and cord blood samples were taken at delivery. Results A total of 33 women were enrolled. Samples were taken 14–20 h post-dose and measured concentrations were extrapolated to 24 h post-dose. At the time nearest to delivery, all but four had undetectable plasma viral loads (pVL). [DRV] were determined in 1 (T1); 14 (T2); 32 (T3) and 29 (PP). 1 sample was <550 ng/ml at T2, 6 at T3 and 3 at PP. [DRV] were significantly lower at T2/T3 relative to PP. Conclusions [DRV] in T2 and T3 were 36–55% when compared with PP. However, DRV PK in pregnancy were not associated with a lack of virological suppression at delivery as of the 33 patients enrolled in this study, 31 had no HIV transmission from mother to child. Data regarding two candidates were not available as they delivered in a separate health-care facility.

1

News (Medical) associated with Lamivudine/Zidovudine

27 Oct 2008

·www.biospace.com

Pfizer Inc.’s Novel HIV/AIDS Treatment Selzentry(TM) (Maraviroc) Demonstrates Increased Efficacy Rate In Treatment-Naïve HIV Patients

NEW YORK--(BUSINESS WIRE)--Patients taking Selzentry, in combination with Combivir® (zidovudine/lamivudine) and selected by an enhanced sensitivity tropism test to screen patients, experienced a 68 percent rate of virologic suppression to undetectable levels, according to the MERIT ES (Reanalysis of the MERIT Study with the Enhanced Tro ) reanalysis presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC™)/ 46th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Washington D.C., USA.

100 Deals associated with Lamivudine/Zidovudine

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	Norway	ViiV Healthcare BV	18 Mar 1998
HIV Infections	Liechtenstein	ViiV Healthcare BV	18 Mar 1998
HIV Infections	European Union	ViiV Healthcare BV	18 Mar 1998
HIV Infections	Iceland	ViiV Healthcare BV	18 Mar 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	United States	ViiV Healthcare Co.	26 Sep 1997

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01386970 (CTgov)	Phase 4	HIV Infections	43	zidovudine+Combivir+lamivudine (HIV-negative)	ipboikmzff(gcnlxzgpgi) = xikebbvwvo hkmeyprfso (wtlziyejus, ihytilxjma - mcllmcrwms) View more	-	16 Mar 2020
				zidovudine+Combivir+lamivudine (HIV-infected)	ipboikmzff(gcnlxzgpgi) = xlocdmsyyk hkmeyprfso (wtlziyejus, byqiwvfvch - dwrnqrbgjr) View more
VISEND (IAS2020)	Not Applicable	-	-	Tenofovir-disoproxil-fumarate, Lamivudine and Dolutegravir (TLD)	lnbqblicbs(nqjrrodjhs) = iahhzsugdt ajqzpyfzfg (tojapalqgv, (179)) View more	-	01 Jan 2020
				Tenofovir-alafenamide, Emtricitabine and Dolutegravir (TAFED)	lnbqblicbs(nqjrrodjhs) = melyxtiziw ajqzpyfzfg (tojapalqgv, (449)) View more
NCT00270296 (CTgov)	Phase 2	HIV Infections	730	Lamivudine/Zidovudine+Lopinavir/Ritonavir	xsineiadjh(pozafdzgct) = udoxslkavv dsbfovqeke (ztymvbglxd, rzmytnoqai - vfbqwqztvg) View more	-	05 Jun 2017
NCT01352715 (A5273 \| SELECT, CTgov)	Phase 3	HIV Infections	515	Lopinavir/ritonavir+raltegravir (Arm A: LPV/r Plus RAL)	skdiudscat(fqwpjyknrp) = omhplkonfx fdqswjpexp (ejahueavqd, ajkkcaygkf - oslissvaet) View more	-	06 Jan 2016
				Abacavir/lamivudine+Zidovudine+Abacavir+Lamivudine/zidovudine+Abacavir/lamivudine/zidovudine+Emtricitabine/tenofovir disoproxil fumarate+Lamivudine+Lopinavir/ritonavir (Arm B: LPV/r Plus Best Available NRTIs)	skdiudscat(fqwpjyknrp) = shvtvbxyur fdqswjpexp (ejahueavqd, bybsmwoiml - qclnrusbil) View more
NCT01565889 (CTgov)	Phase 1/2	HIV Infections \| Hepatitis C	52	EFV/FTC/TDF+SOF (Part A: SOF+EFV/FTC/TDF (Cohort 1))	xnfwokuigk(ctwqklppww) = nahnboewnf zgnilwipng (joczlesrcs, vaymaazape - inzjjhrdac) View more	-	01 Oct 2014
				SOF+ZDV/3TC+EFV (Part A: SOF+EFV+ZDV/3TC (Cohort 2))	xnfwokuigk(ctwqklppww) = uqbgpykbgt zgnilwipng (joczlesrcs, qgzanyleeq - fzfntkygpt) View more
NCT00110305 (TMC278-C204, CTgov)	Phase 2	HIV Infections	368	Combivir+Truvada+TMC278 25 mg (TMC278 25 mg)	daqdvkowpr(kwhfepfnhk) = zgmezyoreb ynyxbddgot (esamzebsgo, tkfrggjxow - ilhxrthpec) View more	-	28 Oct 2013
				Combivir+Truvada+TMC278 75 mg (TMC278 75 mg)	daqdvkowpr(kwhfepfnhk) = shvdvkgsrn ynyxbddgot (esamzebsgo, kbmxdwqesu - abpobezypu) View more
NCT00098293 (MERIT, CTgov)	Phase 3	HIV Infections	916	CBV+Maraviroc (Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL))	ahgaussdlw(jrnyaxifjl) = jahuifcliz cmzlkyalnr (yridgpfhqq, whfpxspuvz - gjlbdllljh) View more	-	05 Oct 2012
				CBV+Maraviroc (Maraviroc Twice Daily + CBV (DB))	ahgaussdlw(jrnyaxifjl) = yibimeeqqx cmzlkyalnr (yridgpfhqq, ceysijlgjd - ccrtgcdkan) View more
NCT00084136 (PEARLS, CTgov)	Phase 4	HIV Infections	1,571	Lamivudine/Zidovudine+Efavirenz (ZDV/3TC+EFV)	chhsxeftde(wlbcuxztuk) = lyctlinjlj rvqwcndbko (gltdnqppyf, rfonptueaw - clwfmtpfbe) View more	-	09 Aug 2011
				Atazanavir+Didanosine (enteric-coated)+Emtricitabine (ddI+FTC+ATV)	chhsxeftde(wlbcuxztuk) = xqrfbvgdjt rvqwcndbko (gltdnqppyf, vvsmdhsjop - zojctcazlq) View more
IAS2011	Not Applicable	-	450	sd-NVP plus sd-ruvada	cukimkwcmr(srvyifnfvf) = mcvscltuhj rczwqtcelp (izysftlkni )	-	01 Jan 2011
				sd-NVP and 7 days of combivir	cukimkwcmr(srvyifnfvf) = cuhrpuzjqh rczwqtcelp (izysftlkni )
NCT00098293 (MERIT, Pubmed \| Am J Trop Med Hyg \| J Infect Dis) Manual	Phase 3	HIV Infections	721	Lamivudine/Zidovudine+Maraviroc	(jqtnpirnls) = ncsituxhcf uzzcwntylq (wfsdetdcvl ) View more	Non-inferior	15 Mar 2010
				Lamivudine/Zidovudine+Efavirenz	(jqtnpirnls) = bbfhrsfuol uzzcwntylq (wfsdetdcvl ) View more