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NCT05208814
A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects
Phase 1 trial testing TPN171H single dose in Pulmonary Arterial Hypertension in 16 participants. Completed in 25 October 2022.
25 October 2022
Quick facts
| Lead sponsor | Vigonvita Life Sciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 31 March 2022 |
| Primary completion | 25 October 2022 |
| Estimated completion | 25 October 2022 |
| Sites | 2 locations across China |
Drugs / interventions tested
- TPN171H single dose — full drug profile →
Conditions studied
- Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
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.
Verify or expand the search:
- PubMed search for NCT05208814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Vigonvita Life Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05208814 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vigonvita Life Sciences
- Last refreshed: 24 December 2024
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