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NCT05374343
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
Phase 1 trial testing pyroglutamate rongliflozin capsules in Type 2 Diabetes in 32 participants. Status unknown.
15 November 2023
Quick facts
| Lead sponsor | Sunshine Lake Pharma Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 5 May 2022 |
| Primary completion | 15 November 2023 |
| Estimated completion | 13 February 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- pyroglutamate rongliflozin capsules — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Sunshine Lake Pharma Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05374343
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of pyroglutamate rongliflozin capsules
Trials testing the same drug.
- NCT05427682 — A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mil · Phase 1 · unknown
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
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- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Sunshine Lake Pharma Co., Ltd. trials
Trials by the same sponsor.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT05048368 — Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function · Phase 1 · not yet recruiting
- NCT07376200 — Single-ascending Dose Study of HEC-151 Injection · Phase 1 · not yet recruiting
- NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
- NCT07211165 — Clinical Study on the Mass Balance of Clifutinib · Phase 1 · completed
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 NCT05374343 (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 Sunshine Lake Pharma Co., Ltd.
- Last refreshed: 16 May 2022
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/NCT05374343.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing