Delving into the Latest Updates on Shandong Langnuo Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Small molecule drug

Disease domain score

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Technology Platform

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Targets

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Disease Domain	Count

Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

5-HT1A receptor x 5-HT2A receptor x D2 receptor	1

[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study evaluating the test formulation baricitinib tablets (strength: 4 mg) versus the reference formulation baricitinib tablets (Olumiant®, strength: 4 mg) in healthy adult participants in the fasting and fed states

主要目的：研究空腹和餐后状态下单次口服受试制剂巴瑞替尼片（规格：4 mg，生产厂家：山东朗诺制药有限公司）与参比制剂巴瑞替尼片（Olumiant®，规格：4 mg，生产厂家：Lilly S.A.）在健康成年参与者体内的药代动力学，评价空腹和餐后状态下口服两种制剂的生物等效性。次要目的：评估受试制剂巴瑞替尼片（规格：4 mg）和参比制剂巴瑞替尼片（Olumiant®，规格：4 mg）在健康参与者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of a single oral dose of the test preparation baricitinib tablets (specification: 4 mg, manufacturer: Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation baricitinib tablets (Olumiant®, specification: 4 mg, manufacturer: Lilly S.A.) in healthy adult participants in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To evaluate the safety of the test preparation baricitinib tablets (specification: 4 mg) and the reference preparation baricitinib tablets (Olumiant®, specification: 4 mg) in healthy participants.

Start Date11 Jun 2025

Sponsor / Collaborator

Shandong Langnuo Pharmaceutical Co. Ltd.

CTR20251611

/ CompletedNot Applicable

依巴斯汀口崩片在健康受试者中单中心、随机、开放、单剂量空腹和餐后状态下的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of ebastine orodisintegrating tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后给药条件下，山东朗诺制药有限公司生产的依巴斯汀口崩片（10mg）与Almirall, S.A.持证的依巴斯汀口崩片（10mg，商品名：Ebastel Flas）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹和餐后给药条件下，山东朗诺制药有限公司生产的依巴斯汀口崩片（10mg）与Almirall, S.A.持证的依巴斯汀口崩片（10mg，商品名：Ebastel Flas）的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and rate between Ebastine orodisintegrating tablets (10 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. and Ebastine orodisintegrating tablets (10 mg, trade name: Ebastel Flas) licensed by Almirall, S.A. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of Ebastine orodisintegrating tablets (10 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. and Ebastine orodisintegrating tablets (10 mg, trade name: Ebastel Flas) licensed by Almirall, S.A. under fasting and postprandial administration conditions.

Start Date22 May 2025

Sponsor / Collaborator

Shandong Langnuo Pharmaceutical Co. Ltd.

CTR20251602

/ Active, not recruitingNot Applicable

多替诺雷片在健康受试者中单中心、随机、开放、单剂量空腹和餐后状态下的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of dotinoreplast tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后给药条件下，山东朗诺制药有限公司生产的多替诺雷片（2mg）与株式会社富士薬品持证的多替诺雷片（2mg，商品名：URECE®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹和餐后给药条件下，山东朗诺制药有限公司生产的多替诺雷片（2mg）与株式会社富士薬品持证的多替诺雷片（2mg，商品名：URECE®）在健康成年人群中的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of Dotinol Tablets (2 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. and Dotinol Tablets (2 mg, trade name: URECE®) certified by Fuji Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of Dotinol Tablets (2 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. and Dotinol Tablets (2 mg, trade name: URECE®) certified by Fuji Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions.

Start Date12 May 2025

Sponsor / Collaborator

Shandong Langnuo Pharmaceutical Co. Ltd.

100 Clinical Results associated with Shandong Langnuo Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Shandong Langnuo Pharmaceutical Co. Ltd.

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100 Deals associated with Shandong Langnuo Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Shandong Langnuo Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 16 Sep 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

NDA/BLA

1

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