Delving into the Latest Updates on Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Tenofovir Disoproxil Fumarate/Dolutegravir/Lamivudine

Target

HIV integrase x RT

Action

inhibitors

Mechanism

HIV-1 integrase inhibitors(HIV integrase inhibitors), RT inhibitors(Viral reverse transcriptase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication-

Originator Organization

Mylan NV

Active Organization

Strides Pharma, Inc.

Aurobindo Pharma Ltd.

Emcure Pharmaceuticals Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC20H19F2N3NaO5

InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N

CAS Registry1051375-19-9

View All Structures (3)

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

Shanghai Desino Biopharmaceutical Co., Ltd.

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