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NCT05948644Completed

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
Vigonvita Life SciencesPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
TPN171H
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Vigonvita Life Sciences
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 1
Start date
Apr 08, 2019
End date
Oct 14, 2020
Enrollment
10 participants
Primary outcome

Incidence of Treatment-Emergent Adverse Events,Q-T interval,Tmax,Cmax,AUC0~t,AUC0-∞,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 hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05948644
Type
Non-Device Trial
About this record

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.