Delving into the Latest Updates on Lamivudine/Tenofovir disoproxil fumarate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Lamivudine and Tenofovir disoproxil fumarate, LAMIVUDINE/TENOFOVIR, 拉米夫定/富马酸替诺福韦二吡呋酯

+ [3]

Target

RT

Action

inhibitors

Mechanism

RT inhibitors(Viral reverse transcriptase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

Hepatitis B, ChronicHIV Infections

Inactive Indication-

Originator Organization

Mylan NV

Active Organization

Anhui Baker Biopharmaceutical Co., Ltd.Mylan Laboratories Ltd.

Inactive Organization

Mylan NV

CHARTWELL RX SCIENCES LLC

Aurobindo Pharma Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (28 Feb 2018),

HIV Infections

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC8H11N3O3S

InChIKeyJTEGQNOMFQHVDC-NKWVEPMBSA-N

CAS Registry134678-17-4

View All Structures (2)

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

/ Active, not 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

[+2]

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

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100 Translational Medicine associated with Lamivudine/Tenofovir disoproxil fumarate

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

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1

Literatures (Medical) associated with Lamivudine/Tenofovir disoproxil fumarate

01 Dec 2014·The Pediatric infectious disease journalQ4 · MEDICINE

Pharmacokinetics of Atazanavir/Ritonavir Among HIV-infected Thai Children Concomitantly Taking Tenofovir Disoproxil Fumarate

Q4 · MEDICINE

Article

Author: Torsak Bunupuradah ; Chonnamet Techasaensiri ; Jintanat Ananworanich ; Amornrat Srimuan ; Siriwan Keadpudsa ; Wasana Prasitsuebsai ; Narukjaporn Thammajaruk ; Thaintip Sahakijpicharn ; Thanyawee Puthanakit

BACKGROUND:

Atazanavir/ritonavir (ATV/r) is a recommended once-daily protease inhibitor. Tenofovir disoproxil fumarate (TDF) can reduce ATV exposure. The authors studied ATV pharmacokinetic (PK) parameters among children who received atazanavir/ritonavir co-administered with TDF.

METHODS:

HIV-infected children aged 6-18 years with a body weight of 25-50 kg were eligible. Branded ATV 200 mg/capsule was taken with generic ritonavir 100 mg/tablet once daily plus TDF and lamivudine. A 24-hour PK study was performed at week 4 at t = 0 (pre-dose), 2, 4, 6, 8, 10, 12 and 24 hours. PK parameters were calculated using non-compartmental methods with WinNonlin software. Targeted ATV AUC 0-24 was 15 mg h/L and C trough was 0.15 mg/L. Comparisons of geometric means of ATV PK parameters between different weight bands were made using regression models.

RESULTS:

Eighteen HIV-infected children with a median (IQR) age of 13 (11-14) years were enrolled. Median (range) body weight and body surface area were 35 (25-42) kg and 1.21 (0.96-1.35) m2, respectively. Median (IQR) CD4 cell count was 735 (540-1233) cells/mm3. Median (range) of ATV was 164 (145-209) mg/m2. Geometric mean (SD) ATV AUC 0-24 was 35.05 (1.06) mg h/L, and ATV C trough was 0.31 (1.13) mg/L. No child had ATV AUC 0-24 or C trough below target levels. There were no significant differences in PK parameters among weight bands.

CONCLUSION:

Atazanavir/ritonavir 200/100 mg dosing provided adequate ATV AUC 0-24 when used with TDF in HIV-infected Thai children weighing between 25 and 50 kg.

100 Deals associated with Lamivudine/Tenofovir disoproxil fumarate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J05AR12	-

R&D Status

10 top approved records.

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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TiP Study (IAS2016)	Not Applicable	Hepatitis B \| HIV Infections	35	Tenofovir/lamivudine	xnlxqxlbcl(ndvndjdmoo) = acctwayqjj tpcuqexico (hehhcbuoce ) View more	-	01 Jan 2016
				Lamivudine	xnlxqxlbcl(ndvndjdmoo) = eogxyxxwxb tpcuqexico (hehhcbuoce ) View more
Pubmed \| Pediatr Infect Dis J	Not Applicable	HIV Infections	18	Atazanavir/ritonavir 200/100 mg	ykhiynepfk(qlymasmpch) = ekwowwmqgy wylszapbnh (kidkyhlqms )	-	01 Dec 2014
IAS2004	Not Applicable	-	-	Tenofovir DF (TDF) 300 mg and 300 mg 3TC	ipfctyjfzf(xmesmwkwsk) = epyhqlwhsw vwhhgraswy (nounjoxpxw ) View more	-	01 Jan 2004
				AZT/3TC	ipfctyjfzf(xmesmwkwsk) = bnvclhzbhu vwhhgraswy (nounjoxpxw ) View more