Last reviewed · How we verify
NCT04841720
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK16149 Capsules and Metformin Hydrochloride Tablets
Phase 1 trial testing HSK16149 in Diabetic Neuropathies in 22 participants. Status unknown.
30 June 2021
Quick facts
| Lead sponsor | Haisco Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 1 April 2021 |
| Primary completion | 30 June 2021 |
| Estimated completion | 15 August 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- HSK16149 — full drug profile →
- Metformin Hydrochloride tablet
- HSK16149+Metformin（phase 3） — full drug profile →
Conditions studied
- Diabetic Neuropathies — all drugs for Diabetic Neuropathies →
- Diabetic Neuropathy Peripheral — all drugs for Diabetic Neuropathy Peripheral →
Sponsor
Haisco Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 50, any sex, with Diabetic Neuropathies or Diabetic Neuropathy Peripheral. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04841720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HSK16149
Trials testing the same drug.
- NCT05916573 — A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment · Phase 1 · completed
Other recruiting trials for Diabetic Neuropathies
Currently open trials in the same condition.
- NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
- NCT06745544 — Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes · NA · recruiting
- NCT06483620 — Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire · recruiting
- NCT06674980 — Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DF · NA · recruiting
- NCT06798181 — Neuropathic Pain and Type II Diabetic Patients · recruiting
Other Haisco Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT07533786 — A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdomina · Phase 2 · not yet recruiting
- NCT07519070 — A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44 · Phase 3 · not yet recruiting
- NCT07503587 — Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07521345 — A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healt · Phase 1 · recruiting
- NCT07335055 — A Study for HSK47388 in Participants With Ulcerative Colitis · Phase 2 · recruiting
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 NCT04841720 (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 Haisco Pharmaceutical Group Co., Ltd.
- Last refreshed: 12 April 2021
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/NCT04841720.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing