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

主要目的：考察中国健康受试者在空腹/餐后条件下单剂量口服上海迪赛诺医药集团股份有限公司生产的受试制剂（多替拉韦拉米夫定替诺福韦片（规格：50mg/300mg/300mg））与联合服用参比制剂（多替拉韦钠片（特威凯®，规格：50mg）+拉米夫定片（EPIVIR®，规格：300mg）+富马酸替诺福韦二吡呋酯片（韦瑞德®，规格：300mg））后的体内药代动力学特征，评价受试制剂与参比制剂的生物等效性。次要目的：评价单剂量口服上海迪赛诺医药集团股份有限公司生产的受试制剂（多替拉韦拉米夫定替诺福韦片（规格：50mg/300mg/300mg））与联合服用参比制剂（多替拉韦钠片（特威凯®，规格：50mg）+拉米夫定片（EPIVIR®，规格：300mg）+富马酸替诺福韦二吡呋酯片（韦瑞德®，规格：300mg））在中国健康受试者中的安全性。

[Translation]

Main purpose: To investigate the in vivo pharmacokinetic characteristics of the test preparation (Dolutegravir Lamivudine Tenofovir Tablets (Specifications: 50mg/300mg/300mg)) produced by Shanghai Desano Pharmaceutical Group Co., Ltd. and the reference preparation (Dolutegravir Sodium Tablets (Tivicay®, Specification: 50mg) + Lamivudine Tablets (EPIVIR®, Specification: 300mg) + Tenofovir Disoproxil Fumarate Tablets (Viread®, Specification: 300mg)) in Chinese healthy subjects after single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary objective: To evaluate the safety of a single oral dose of the test formulation (dolutegravir lamivudine and tenofovir disoproxil fumarate tablets (specifications: 50 mg/300 mg/300 mg)) produced by Shanghai Desano Pharmaceutical Group Co., Ltd. and the combined administration of the reference formulation (dolutegravir sodium tablets (Tivica®, specification: 50 mg) + lamivudine tablets (EPIVIR®, specification: 300 mg) + tenofovir disoproxil fumarate tablets (Viread®, specification: 300 mg)) in healthy Chinese subjects.

Start Date05 Aug 2024

Sponsor / Collaborator

Shang Hai Di SAi Nuo Sheng Wu Yi Yao You Xian Gong Si

NCT06485154 / Active, not recruitingPhase 4

Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial

This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.

Start Date01 Jun 2024

Sponsor / Collaborator

University of the Witwatersrand

[+1]

TCTR20241030006 / CompletedNot ApplicableIIT

Renal function effect of ARV combination regimen Tenofovir/Lamivudine/Dolutegravir and Tenofovir/Emtricitabine/Rilpivirine in HIV patients

Start Date01 Jun 2023

Sponsor / Collaborator-

100 Clinical Results associated with Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate

100 Translational Medicine associated with Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate

100 Patents (Medical) associated with Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate

100 Deals associated with Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J05AR27	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	-	Aurobindo Pharma Ltd.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	US	Strides Pharma, Inc.	-
HIV Infections	NDA/BLA	US	Emcure Pharmaceuticals Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


VISEND (IAS2022)	Not Applicable	HIV Infections	837	Tenofovir Alafenamide (TAF)/Emtricitabine (FTC)/Dolutegravir (DTG)	pemyluyarz(mvourcxfki) = 2 individuals were discontinued due to bone related events wpxqftaszw (muwgnmpyft ) View more	-	01 Jan 2022
				Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)/Dolutegravir (DTG)
VISEND (IAS2022)	Not Applicable	HIV Infections	-	Tenofovir alafenamide (TAF)/emtricitabine (FTC)/dolutegravir (DTG)	lwxfyjmcra(fajsqzqltw) = pcztrkxdtn vlfgdttnsg (ddnelppshp ) View more	-	01 Jan 2022
				Tenofovir disoproxil fumarate (TDF)/lamivudine (3TC)/dolutegravir (DTG)	lwxfyjmcra(fajsqzqltw) = nkcyemiadh vlfgdttnsg (ddnelppshp ) View more
IAS2017	Not Applicable	Pregnancy	-	Dolutegravir / tenofovir / emtricitabine (DTG/TDF/FTC)	sxdiughego(iqqsbinvgk) = nrvpqdssop pmazczcxqq (crmttglvln ) View more	-	01 Jan 2017
				Efavirenz / tenofovir / emtricitabine (EFV/TDF/FTC)	sxdiughego(iqqsbinvgk) = uyqkovochn pmazczcxqq (crmttglvln ) View more

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