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The Safety, Tolerability, and Pharmacokinetics of TPN171H Tablets in Patients With Pulmonary Arterial Hypertension - Trial NCT05948644

Access comprehensive clinical trial information for NCT05948644 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vigonvita Life Sciences and is currently Completed. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05948644
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05948644
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The Safety, Tolerability, and Pharmacokinetics of TPN171H Tablets in Patients With Pulmonary Arterial Hypertension
Phase Ib Clinical Study on the Safety, Tolerability, and Pharmacokinetics of TPN171H Tablets in the Treatment of Pulmonary Arterial Hypertension (PAH) Patients

Study Focus

TPN171H

Interventional

drug

Sponsor & Location

Vigonvita Life Sciences

Shanghai, China

Timeline & Enrollment

Phase 1

Apr 08, 2019

Oct 14, 2020

10 participants

Primary Outcome

Incidence of Treatment-Emergent Adverse Events,Q-T interval,Tmax,Cmax,AUC0~t,AUC0-โˆž,Terminal half-life (t 1/2),Apparent distribution volume (Vd/F),Clearance rate (CL/F),Mean Residence Time(MRT)

Summary

Exploring the safety, tolerability, and pharmacokinetic (PK) characteristics of oral TPN171H
 tablets in patients with Pulmonary Arterial Hypertension under continuous multiple
 administration conditions, providing a basis for determining the administration plan and
 recommended dosage in phase II clinical study.

ICD-10 Classifications

Primary pulmonary hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT05948644

Non-Device Trial