Last reviewed · How we verify
NCT04158102
Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects
Phase 1 trial testing Bupivacaine liposome injectable suspension in Healthy Subjects in 20 participants. Completed in 26 December 2019.
17 December 2019
Quick facts
| Lead sponsor | Nuance Pharma (shanghai) Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 7 November 2019 |
| Primary completion | 17 December 2019 |
| Estimated completion | 26 December 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bupivacaine liposome injectable suspension — full drug profile →
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Nuance Pharma (shanghai) Co., Ltd
Who can join
Adults 18 to 55, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacokinetics and safety of liposomal bupivacaine after local infiltration in healthy Chinese adults: a phase 1 study.
Cheung BM, Ng PY, Liu Y, Zhou M, et al · · 2021 · cited 11× · PMID 34315419 · DOI 10.1186/s12871-021-01407-5
Verify or expand the search:
- PubMed search for NCT04158102
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bupivacaine liposome injectable suspension
Trials testing the same drug.
- NCT06471348 — Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine · NA · recruiting
- NCT06547255 — Exparel Versus Bupivacaine in Post-operative Pain Control · Phase 4 · completed
- NCT04102267 — Extended Delivery of Bupivacaine Study in Herniorrhaphy · Phase 4 · completed
Other recruiting trials for Healthy Subjects
Currently open trials in the same condition.
- NCT07222020 — Phase 1 Study of Intravaginal KB15A · Phase 1 · recruiting
- NCT07350538 — The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL · NA · active not recruiting
- NCT07304791 — This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and P · Phase 1 · recruiting
- NCT07059858 — Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities · recruiting
- NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting
Other Nuance Pharma (shanghai) Co., Ltd trials
Trials by the same sponsor.
- NCT05743075 — A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obs · Phase 3 · completed
- NCT05758428 — A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects · Phase 1 · completed
- NCT05382546 — A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects · 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 NCT04158102 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nuance Pharma (shanghai) Co., Ltd
- Last refreshed: 18 January 2020
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/NCT04158102.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing