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NCT05208814

A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects

Completed Phase 1 Last updated 24 December 2024
What this trial tests

Phase 1 trial testing TPN171H single dose in Pulmonary Arterial Hypertension in 16 participants. Completed in 25 October 2022.

Timeline
31 March 2022
Primary endpoint
25 October 2022
25 October 2022

Quick facts

Lead sponsorVigonvita Life Sciences
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date31 March 2022
Primary completion25 October 2022
Estimated completion25 October 2022
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Vigonvita Life Sciences — full company profile →

Who can join

Adults 18 to 70, any sex, with Pulmonary Arterial Hypertension or Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets after single dose oral administration, so as to provide basis for formulating clinical medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H tablets in patients with renal insufficiency and healthy subjects

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Pulmonary Arterial Hypertension

Currently open trials in the same condition.

Other Vigonvita Life Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05208814.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing