- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Trial completion, Trial completion date, Trial primary completion date: Effect of TPN171H on Spermatogenesis (clinicaltrials.gov) - Feb 21, 2023 P1, N=18, Completed, Recruiting --> Completed Recruiting --> Completed | Trial completion date: Apr 2023 --> Dec 2022 | Trial primary completion date: Apr 2023 --> Dec 2022
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Enrollment open: Effect of TPN171H on Spermatogenesis (clinicaltrials.gov) - Dec 7, 2022 P1, N=18, Recruiting, Recruiting --> Completed | N=56 --> 16 | Trial completion date: Dec 2023 --> Oct 2022 Not yet recruiting --> Recruiting
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
New P1 trial: Effect of TPN171H on Spermatogenesis (clinicaltrials.gov) - Oct 19, 2022 P1, N=18, Not yet recruiting,
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
PK/PD data, Journal: Pharmacokinetics, mass balance, and metabolism of [C]TPN171, a novel PDE5 inhibitor, in humans for the treatment of pulmonary arterial hypertension. (Pubmed Central) - Jun 10, 2022 Cytochrome P450 3A4 (CYP3A4) mainly catalyzed the formation of metabolites, and CYP2E1 and CYP2D6 were involved in the oxidative metabolism of TPN171 to a lesser extent. According to the incubation data, M1 was mainly metabolized to M1G by UDP-glucuronosyltransferase 1A9 (UGT1A9), followed by UGT1A7 and UGT1A10.
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Preclinical, Journal: TPN171H alleviates pulmonary hypertension via inhibiting inflammation in hypoxia and monocrotaline-induced rats. (Pubmed Central) - Jun 10, 2022 The results suggested that TPN171H significantly reduced RVSP and RVHI, and reversed pulmonary vascular remodeling in rats with both models. Furthermore, in in vivo and in vitro research, our data suggested that TPN171H remarkably suppressed cathepsin B-mediated NLRP3 inflammasome activation, which may contribute to its therapeutical function for PH.
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Trial completion: A Study of the Hemodynamic Interactions of TPN171H Tablets & Alcohol in Healthy Male Subjects (clinicaltrials.gov) - May 23, 2022 P1, N=19, Completed, Furthermore, in in vivo and in vitro research, our data suggested that TPN171H remarkably suppressed cathepsin B-mediated NLRP3 inflammasome activation, which may contribute to its therapeutical function for PH. Recruiting --> Completed
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Enrollment open: Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction. (clinicaltrials.gov) - Jan 20, 2022 P3, N=740, Recruiting, Recruiting --> Completed | Trial completion date: Dec 2022 --> Feb 2022 Not yet recruiting --> Recruiting
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Trial completion, Trial primary completion date: Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction (clinicaltrials.gov) - Jan 14, 2022 P2, N=255, Completed, Not yet recruiting --> Recruiting Recruiting --> Completed | Trial primary completion date: Apr 2021 --> Jul 2021
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Clinical, P1 data, PK/PD data, Journal: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TPN171H, a Novel Phosphodiesterase Type 5 Inhibitor, in Healthy Subjects. (Pubmed Central) - Dec 16, 2021 TPN171H was safe and generally tolerated in healthy subjects. Based on the half-life, food effect, and safety profile of TPN171H, we recommend a once-daily, post-meal administration of TPN171H in subsequent clinical studies in healthy subjects and patients with PAH.
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Trial completion date, Trial primary completion date: Acute Haemodynamic Study of TPN171H in Patients With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Oct 29, 2021 P2, N=60, Recruiting, Based on the half-life, food effect, and safety profile of TPN171H, we recommend a once-daily, post-meal administration of TPN171H in subsequent clinical studies in healthy subjects and patients with PAH. Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Jul 2022
- |||||||||| simmerafil (TPN171H) / Shanghai Inst. of Materia Medica, Vigonvita Life Sci, Topharman
Trial completion: Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects (clinicaltrials.gov) - Feb 25, 2021 P1, N=6, Completed, Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Jul 2022 Recruiting --> Completed
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