[Translation] A randomized, open-label, two-dose, single-dose, two-cycle, two-sequence bioequivalence study of lamivudine and tenofovir tablets (300 mg/300 mg) in healthy subjects under fasting and fed conditions

主要目的：以石家庄龙泽制药股份有限公司研制的拉米夫定替诺福韦片（规格：300mg/300mg）为受试制剂，按生物等效性试验的有关规定，与Mylan Laboratories Ltd 的拉米夫定替诺福韦片（商品名：Cimduo®，规格：300mg/300mg，参比制剂）对比在健康人体内空腹和餐后条件下的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂拉米夫定替诺福韦片和参比制剂拉米夫定替诺福韦片（商品名：Cimduo®）在健康受试者中的安全性。

[Translation]

Main purpose: Lamivudine-tenofovir tablets (specification: 300mg/300mg) developed by Shijiazhuang Longze Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of Lamivudine-tenofovir tablets (trade name: Cimduo®, specification: 300mg/300mg, reference preparation) of Mylan Laboratories Ltd were compared with those of Lamivudine-tenofovir tablets (trade name: Cimduo®, specification: 300mg/300mg, reference preparation) in healthy subjects to investigate the bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation Lamivudine-tenofovir tablets and the reference preparation Lamivudine-tenofovir tablets (trade name: Cimduo®) in healthy subjects.

Start Date25 Jun 2024

Sponsor / Collaborator

Shijiazhuang Lonzeal Pharmaceuticals Co. Ltd.

NCT05630872 / RecruitingPhase 2IIT

Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB.

Start Date13 Feb 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

CTR20222564 / CompletedNot Applicable

一项随机、开放、两序列自身交叉设计，评价空腹和餐后状态下中国健康受试者单次口服拉米夫定替诺福韦片的生物等效性研究

[Translation] A randomized, open-label, two-sequence self-crossover design to evaluate the bioequivalence of a single oral dose of lamivudine-tenofovir tablets in Chinese healthy subjects in the fasting and fed states

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服江苏诚康药业有限公司（持有人：上海迪赛诺生物医药有限公司）生产的拉米夫定替诺福韦片（规格：拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg）与持证商为Mylan Laboratories Ltd 的拉米夫定替诺福韦片（商品名：Cimduo®，规格：拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单剂量口服拉米夫定替诺福韦片（规格：拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg）受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of Lamivudine-Tenofovir Tablets (Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. (Owner: Shanghai Desano Biopharmaceutical Co., Ltd.) and Lamivudine-Tenofovir Tablets (Trade name: Cimduo®, Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) produced by Mylan Laboratories Ltd. (Trade name: Cimduo®, Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and reference preparation of Lamivudine-Tenofovir Tablets (Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) taken orally as a single dose in healthy Chinese subjects.

Start Date21 Oct 2022

Sponsor / Collaborator

Shanghai Desano Pharmaceuticals Co. Ltd.

100 Clinical Results associated with Lamivudine/Tenofovir disoproxil fumarate

100 Translational Medicine associated with Lamivudine/Tenofovir disoproxil fumarate

100 Patents (Medical) associated with Lamivudine/Tenofovir disoproxil fumarate

Literatures (Medical) associated with Lamivudine/Tenofovir disoproxil fumarate

02 Dec 2000·Presse medicale (Paris, France : 1983)

[Antiretroviral therapies].

Author: Bricaire, F ; Dominguez, S

SPARING ANTIPROTEASES: An antiprotease-sparing strategy can improve compliance and adhesion to antiretroviral treatments. Several studies have demonstrated that switching to neviparin or efavirenz can maintain viral suppression and allow satisfactory rise in CD4 counts with a significant reduction in the neviparin group. A switch to a tritherapy with nucleosides (abacavir) can increase the risk of virological failure but allows an improvement in lipid anomalies, simplified treatment, and better patient adhesion. LIPODYSTROPHY SYNDROMES: These syndromes develop in 30 to 50% of the cases depending on the study and appear to be linked to the duration of exposure to antiretroviral agents. Along with the associated metabolic anomalies, lipodystrophy plays a role in the cardiovascular risk related to these treatments. NEW ANTIRETROVIRAL DRUGS: Several clinical trials have been devoted to new antiretroviral drugs. DAPD was found to have a dose-dependent antiretroviral effect with good tolerance. A new antiprotease (BMS 232 632) offers the advantage of a single daily dose with good tolerance and good effectiveness compared with the reference treatment including nelfinavir. TDF (tenofovir disoproxyl fumarate) is a nucleotidic analogue of reverse transcriptase. Given in a single daily dose monotherapy regimen, it can provide prolonged retroviral suppression. Compared with nelfinavir, ABT 378 gave significantly higher viral loads < 400 copies/ml at 24 weeks with an identical clinical tolerance but with an advantage for cholesterol and triglyceride levels.

100 Deals associated with Lamivudine/Tenofovir disoproxil fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B, Chronic	CN	Anhui Baker Biopharmaceutical Co., Ltd.	15 Jan 2019
HIV Infections	US	Mylan Laboratories Ltd.	28 Feb 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2022	Not Applicable	-	-	Sofosbuvir and Velpatasvir (S+V)	nxucenxhlg(ymitebzokv) = ctyfifywwu ugdhqhefcl (dvjgdhycyh )	-	21 May 2022
				Tenofovir, Lamivudine and Dolutegravir (TLD)	nxucenxhlg(ymitebzokv) = yaidmbqzjb ugdhqhefcl (dvjgdhycyh )
IAS2020	Not Applicable	Second line	1,017	Tenofovir/3TC	cjnccfdzrp(dcqkqohily) = gcuzufbhsu lsgcsyirfz (zxynlmview ) View more	-	01 Jan 2020
				Zidovudine/3TC	cjnccfdzrp(dcqkqohily) = yztvrfplbz lsgcsyirfz (zxynlmview ) View more
IAS2018	Not Applicable	-	33	Lamivudine, TenofovirDisoproxilFumarate and Dolutegravir tablets (300mg/300mg/50mg)	(pworgcsqly) = wcjgctxtxg qvnebzadvw (aeawqhizgs ) View more	-	01 Jan 2018
				EPIVIR® tablets (300mg)	(pworgcsqly) = vcoirhadro qvnebzadvw (aeawqhizgs ) View more
TiP Study (IAS2016)	Not Applicable	Hepatitis B \| HIV Infections	35	Tenofovir/lamivudine	lnjvgwmflc(rowpyjjoqn) = ofaliyfwwm drljbecgxy (eowkuccqwm ) View more	-	01 Jan 2016
				Lamivudine	lnjvgwmflc(rowpyjjoqn) = svqwtlwucg drljbecgxy (eowkuccqwm ) View more
Pubmed \| AIDS Behav	Not Applicable	HIV Infections	-	Oral Tenofovir/Emtricitibine	bsshgtqnpw(ecsawwzwvn) = egbzyqljns kofwedwdhn (zalhhvfvgg ) View more	-	01 May 2015
DART trial (IAS2009)	Not Applicable	-	3,316	Zidovudine-lamivudine plus Tenofovir DF	cpggiqcjlq(rdimrvmfsn) = osegbbzasw dmifensnya (vavztihikq )	-	01 Jan 2009
				Nevirapine	tkgxqrjfvb(dwoubqprex) = inggavwhvt oxrgcmpviv (ikaygsmwhx ) View more
Staccato trial (Pubmed \| J Antimicrob Chemother)	Not Applicable	Toxicity	-	Stavudine/didanosine	eealjmsjzn(vuinrwhmfd) = izihehzpuh vmngspckxv (lniqmvknpj ) View more	-	01 Jun 2008
				Tenofovir/lamivudine	eealjmsjzn(vuinrwhmfd) = klssbpdssg vmngspckxv (lniqmvknpj ) View more
IAS2007	Not Applicable	-	74	Combivir/tenofovir	(hpczhkvben) = wvhniirjgh hgjagmxwhu (ytkbqnavbh ) View more	-	01 Jan 2007
				stavudine/lamivudine/tenofovir	(qbsjrlmuzx) = guqbhllowb imexbtrchv (qkvtklfcab )
IAS2005	Not Applicable	HIV Infections	88	Tenofovir-Didanosine	(tmhihhkifz) = zgamoqmmei ddwkkdlluv (btqfpjjzkm )	-	01 Jan 2005
				Tenofovir-Lamivudine	(tmhihhkifz) = xcjqyvhkro ddwkkdlluv (btqfpjjzkm )
IAS2005	Not Applicable	Hepatitis B, Chronic \| HIV Infections	-	Tenofovir plus Lamivudine	(tocvwylmvf) = pcrbdmpxox roarjswvri (eqxrsbkaya )	-	01 Jan 2005
				Tenofovir	(tocvwylmvf) = cydcnfebmq roarjswvri (eqxrsbkaya )

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