[Translation] A randomized, open-label, single-center, single-dose, two-formulation, two-sequence, two-period, two-cohort, double-crossover bioequivalence study was conducted to evaluate the oral administration of two formulations of arginine ibuprofen granules [0.4 g (in terms of ibuprofen)] in fasting and fed states in healthy Chinese adult subjects.

本研究主要目的旨在证明两种不同状态下（餐后队列和空腹队列），精氨酸布洛芬颗粒[规格：0.4 g（以布洛芬计）]与精氨酸布洛芬颗粒[规格：0.4 g（以布洛芬计），商品名：司百得]的生物等效性，次要目的为评估受试制剂和参比制剂的PK和安全性特征。

[Translation]

The primary objective of this study was to demonstrate the bioequivalence of arginine ibuprofen granules [specification: 0.4 g (in terms of ibuprofen)] and arginine ibuprofen granules [specification: 0.4 g (in terms of ibuprofen), trade name: Spodek] under two different conditions (fed cohort and fasting cohort). The secondary objective was to evaluate the PK and safety characteristics of the test preparation and the reference preparation.

Start Date19 Apr 2023

Sponsor / Collaborator

Haleon (Suzhou) Pharmaceutical Co. Ltd.

CTR20150272

/ CompletedPhase 4

任捷在中国甲型血友病受试者中常规治疗环境下的安全性和有效性的开放性、单臂、注册后实用性临床试验

[Translation] An open-label, single-arm, post-registration pragmatic clinical trial of the safety and efficacy of sedatives in Chinese hemophilia A subjects under conventional treatment settings

在中国常规治疗环境下，评估甲型血友病受试者接受任捷后出现的医学重要事件（FVIII抑制物形成）的情况。次要目的：在中国普通医疗单位，评估甲型血友病受试者接受任捷的总体安全性（包括AE和SAE发生率）和任捷的按需治疗和手术预防治疗的有效性。探索性目的：在接受按需治疗的儿童受试者中评估患者报告结局。

[Translation]

To evaluate the occurrence of medically important events (FVIII inhibitor formation) in hemophilia A subjects receiving Renjie in the routine treatment setting in China. Secondary objective: To evaluate the overall safety (including AE and SAE incidence) of Renjie in hemophilia A subjects receiving Renjie in general medical institutions in China and the effectiveness of Renjie for on-demand treatment and surgical prophylaxis. Exploratory objective: To evaluate patient-reported outcomes in pediatric subjects receiving on-demand treatment.

Start Date15 Apr 2015

Sponsor / Collaborator

Wyeth Pharmaceuticals, Inc.

[+2]

CTR20140678

/ Active, not recruitingPhase 1

贝赋（诺那凝血素α）在中国男性乙型血友病受试者中的开放性、单剂量药代动力学研究

[Translation] An open-label, single-dose pharmacokinetic study of Befu (nonacoag alpha) in Chinese male subjects with hemophilia B

主要目的：确定中国男性乙型血友病受试者中贝赋的单剂量药代动力学特征次要目的：评价中国男性乙型血友病受试者中贝赋的单剂量安全性和耐受性

[Translation]

Primary objective: To determine the single-dose pharmacokinetic characteristics of Befu in Chinese male subjects with hemophilia B Secondary objective: To evaluate the single-dose safety and tolerability of Befu in Chinese male subjects with hemophilia B

Start Date02 Mar 2015

Sponsor / Collaborator

Haleon (Suzhou) Pharmaceutical Co. Ltd.

[+2]

100 Clinical Results associated with Haleon (Suzhou) Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Haleon (Suzhou) Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Haleon (Suzhou) Pharmaceutical Co. Ltd.

12 Aug 2024·The Journal of Sexual Medicine

(147) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES SELF-ESTEEM AND RELATIONSHIPS IN MEN WITH ERECTILE DYSFUNCTION: RESULTS FROM TWO CLINICAL TRIALS

Author: Honig, S ; Fisher, M ; Brock, G ; Yafi, F

AbstractIntroductionErectile dysfunction (ED) negatively impacts self-esteem, confidence, relationships, and quality of life while effective treatment of ED improves these measures. MED3000 is a FDA-cleared, topical treatment for ED that has been shown to be effective for the treatment ED, but effects on psychosocial outcomes have not been reported.ObjectiveTo assess the effects of MED3000 in men with ED using the Self-esteem and Relationship (SEAR) questionnaire.MethodsTwo multicenter studies were performed (n = 298 total). Both studies enrolled patients with a clinical diagnosis of ED for >3 months based the National Institutes of Health Consensus Statement. The first (Study 1) had a duration of 12 weeks and the second (Study 2) was 24 weeks. Subjects or their female partners were instructed to apply MED3000 immediately prior to sexual intercourse and subjects were instructed to make at least 4 intercourse attempts in each of the three or six 4-week periods during treatment. Subjects completed the 14-item SEAR questionnaire every 4 weeks for the duration of the study periods. Results for individual scores were combined and transformed into domain and total scores (1-100, higher scores indicate more favorable responses). Results for non-missing data for each 4-week period were combined to provide a mean change from baseline over 12 (Study 1) or 24 (Study 2) weeks. Significance (P < 0.005 with Bonferroni correction) of mean changes from baseline over 12 or 24 weeks were determined with paired t-tests.ResultsStudy 1 enrolled a total of 250 subjects (mean age □ standard deviation (SD) = 46.8□12.5 years, duration of ED = 27.5□36.5 months, 59.2%, 28.0%, and 12.8% with mild, moderate, or severe ED, respectively). Study 2 enrolled 48 subjects (44 White, 4 Black, 46.1□13.5 years old, duration of ED = 28.9□32.3 months, 39.6%, 35.4%, and 25.0% with mild, moderate, or severe ED). In both studies, MED3000 resulted in statistically significant improvements in total scores and for all individual SEAR domains except Overall Relationship Satisfaction in Study 2 (Table 1). Results from both studies indicated that SEAR total and domain score changes from baseline exceeded the minimal clinically meaningful improvement (>10 points) for this measure. At the end of the trial, 81.2% of men in Study 1 and 85.4% in Study 2 felt that sex could be spontaneous. Table 1. SEAR questionnaire results (mean ± SD) Study 1 (N = 250) Study 2 (N = 48) Baseline Change from Baseline over the 12-week Period P-value Baseline Change from Baseline over the 24-week Period P-value Total Score 38.7 ± 15.9 14.7 ± 18.6 < 0.001 44.6 ± 17.5 12.5 ± 16.8 < 0.001 Sexual Relationship and Satisfaction Domain (MCMI >10-point change) 38.1 ± 17.1 15.6 ± 19.9 < 0.001 41.9 ± 19.6 13.8 ± 17.9 < 0.001 Confidence Domain (MCMI >10-point change) 39.4 ± 15.9 13.6 ± 18.9 < 0.001 48.2 ± 16.1 10.8 ± 16.6 < 0.005 Self-esteem Domain (MCMI >10-point change) 38.2 ± 15.4 11.8 ± 17.4 < 0.001 42.6 ± 14.6 11.1 ± 18.3 < 0.001 Overall Relationship Satisfaction Domain (MCMI not defined) 41.9 ± 23.4 17.1 ± 28.1 < 0.001 59.4 ± 27.2 10.1 ± 24.5 0.009 MICI, minimal clinically meaningful improvement.ConclusionsStudy results from two multicenter trials showed that MED3000 resulted in statistically significant and clinically meaningful improvements in self-esteem and relationships as reflected by SEAR total and domain scores. These findings provide further support for the benefit of MED3000 in men with ED.DisclosureYes, this is sponsored by industry/sponsor: Futura Pharmaceuticals/Haleon.Clarification: Industry initiated, executed and funded study.Any of the authors act as a consultant, employee or shareholder of an industry for: Futura and Haleon.

01 Aug 2011·American Journal of TransplantationQ1 · MEDICINE

The ORION Study: Comparison of Two Sirolimus-Based Regimens versus Tacrolimus and Mycophenolate Mofetil in Renal Allograft Recipients

Q1 · MEDICINE

Article

Author: Sandra Cockfield ; S. Steinberg ; SandiSee Tai ; Karl Martin Wissing ; Christophe Legendre ; Josep María Grinyõ ; Graeme Randolph Russ ; Stuart Flechner ; Maciej Glyda

Safety and efficacy of two sirolimus (SRL)-based regimens were compared with tacrolimus (TAC) and mycophenolate mofetil (MMF). Renal transplantation recipients were randomized to Group 1 (SRL+TAC; week 13 TAC elimination [n = 152]), Group 2 (SRL + MMF [n = 152]) or Group 3 (TAC + MMF [n = 139]). Group 2, with higher-than-expected biopsy-confirmed acute rejections (BCARs), was sponsor-terminated; therefore, Group 2 two-year data were limited. At 1 and 2 years, respectively, graft (Group 1: 92.8%, 88.5%; Group 2: 90.6%, 89.9%; Group 3: 96.2%, 95.4%) and patient (Group 1: 97.3%, 94.4%; Group 2: 95.2%, 94.5%; Group 3: 97.0%, 97.0%) survival rates were similar. One- and 2-year BCAR incidence was: Group 1, 15.2%, 17.4%; Group 2, 31.3%, 32.8%; Group 3, 8.2%, 12.3% (Group 2 vs. 3, p < 0.001). Mean 1- and 2-year modified intent-to-treat glomerular filtration rates (mL/min) were similar. Primary reason for discontinuation was adverse events (Group 1, 34.2%; Group 2, 33.6%; Group 3, 22.3%; p < 0.05). In Groups 1 and 2, delayed wound healing and hyperlipidemia were more frequent. One-year post hoc analysis of new-onset diabetes posttransplantation was greater in TAC recipients (Groups 1 and 3 vs. 2, 17% vs. 6%; p = 0.004). Between-group malignancy rates were similar. The SRL-based regimens were not associated with improved outcomes for kidney transplantation patients.

01 May 2011·HaemophiliaQ2 · MEDICINE

A retrospective study to describe the incidence of moderate to severe allergic reactions to factor IX in subjects with haemophilia B

Q2 · MEDICINE

Article

Author: H. Pollmann ; M. Recht ; A. Tagliaferri ; W. Richey Neuman ; R. Musso ; R. Janco

Using a patient chart review process, we conducted a retrospective study to describe the frequency of allergic reactions in individuals with haemophilia B receiving factor IX (FIX) replacement therapy. The number of allergic reactions in individuals receiving a recombinant FIX (rFIX) product (BeneFix(®)) was then compared with the number of reactions in patients receiving plasma-derived FIX (pdFIX) products. Of the 180 subjects in the study, 163 received rFIX, 88 received pdFIX; 71 received both product types. A total of seven (3.89%) subjects had a moderate or severe allergic reaction to a FIX product (95% confidence interval [CI], 1.06-6.71%). Among those receiving rFIX, four subjects (2.45%) had an allergic reaction (95% CI, 0.08-4.83%). Of individuals taking pdFIX products, three (3.41%) developed an allergic reaction (95% CI, 0-7.20%). It was noted that three (1.84%) of those taking rFIX developed an inhibitor to FIX (95% CI, 0-3.90%), while four (4.55%) of those receiving a pdFIX product developed an inhibitor (95% CI, 0.19-8.90%). Inhibitor development was frequently associated with allergic reaction. These results provide evidence that there is no difference in the frequency of allergic reactions or inhibitor development in individuals receiving rFIX compared with those receiving pdFIX concentrates. The current study and a previous study of similar design have now compared the rate of allergic reactions associated with rFIX and pdFIX concentrates has now been compared in a total of 414 subjects; this represents the largest collection of data to date on this rare complication of haemophilia B therapy.

100 Deals associated with Haleon (Suzhou) Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Haleon (Suzhou) Pharmaceutical Co. Ltd.

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