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NCT05588557
A Phase I Study to Evaluate the Safety and PK of ND-340 in Healthy Volunteers
Phase 1 trial testing Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection in Pain, Postoperative in 24 participants. Completed in 19 March 2024.
19 March 2024
Quick facts
| Lead sponsor | Nang Kuang Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 8 July 2022 |
| Primary completion | 19 March 2024 |
| Estimated completion | 19 March 2024 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection — full drug profile →
- ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension — full drug profile →
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
Nang Kuang Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 20 to 45, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study focuses on ND-340 extended release injection suspension for healthy volunteers with a one-time nerve blockade to determine the safety, tolerability, and pharmacokinetic profile.
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 NCT05588557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Nang Kuang Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07290855 — A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema · Phase 4 · 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 NCT05588557 (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 Nang Kuang Pharmaceutical Co., Ltd.
- Last refreshed: 27 November 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/NCT05588557.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing