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

CHARTWELL RX SCIENCES LLC

Aurobindo Pharma Ltd.

Mylan NV

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]

NCT07006246

/ Active, not recruitingPhase 4

Utilizing Private Pharmacies to Initiate High Risk Young Women and Men on Pre-exposure Prophylaxis (PrEP) in South Africa

This is a funded implementation study designed to evaluate the efficacy of recruiting and retaining high-risk individuals on pre-exposure prophylaxis (PrEP) within multiple private pharmacies (and online platforms in South Africa)

Start Date19 May 2023

Sponsor / Collaborator

University of the Witwatersrand

[+1]

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	nyhufshemb(xxfhhxtzin) = kvhhgvbrni nieyitomzo (ikpkndkest ) View more	-	01 Jan 2016
				Lamivudine	nyhufshemb(xxfhhxtzin) = gbvcwmbjim nieyitomzo (ikpkndkest ) View more
Pubmed \| Pediatr Infect Dis J	Not Applicable	HIV Infections	18	Atazanavir/ritonavir 200/100 mg	hdagzoirag(nyzhsebkee) = jjwiyahxdr hkpdisqarq (tvzteyrhsz )	-	01 Dec 2014
IAS2004	Not Applicable	-	-	Tenofovir DF (TDF) 300 mg and 300 mg 3TC	bjnxbjrtrk(oiojfgpieo) = mdbeplfjhe gvawthfasr (awjvdkhouu ) View more	-	01 Jan 2004
				AZT/3TC	bjnxbjrtrk(oiojfgpieo) = amglextght gvawthfasr (awjvdkhouu ) View more