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NCT04585412
Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
Phase 4 trial testing Palonosetron in Chemotherapy-induced Nausea and Vomiting, Prophylaxis in 16 participants. Completed in 31 December 2020.
24 October 2020
Quick facts
| Lead sponsor | Yung Shin Pharm. Ind. Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 16 |
| Start date | 17 August 2020 |
| Primary completion | 24 October 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Palonosetron — full drug profile →
Conditions studied
- Chemotherapy-induced Nausea and Vomiting, Prophylaxis — all drugs for Chemotherapy-induced Nausea and Vomiting, Prophylaxis →
Sponsor
Yung Shin Pharm. Ind. Co., Ltd. — full company profile →
Who can join
Adults 20 to 45, any sex, with Chemotherapy-induced Nausea and Vomiting, Prophylaxis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.
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 NCT04585412
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Palonosetron
Trials testing the same drug.
- NCT05956899 — Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients · Phase 4 · completed
- NCT04912271 — Granisetron Transdermal Patch for Prophylaxis of Delayed CINV · Phase 3 · unknown
- NCT03817970 — Cisplatin Disposition and Kidney Injury · Phase 3 · active not recruiting
- NCT03586817 — PALONOSETRON X FOSAPREPITANT IN PONV · Phase 4 · unknown
- NCT04060771 — Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery · Phase 3 · unknown
Other Yung Shin Pharm. Ind. Co., Ltd. trials
Trials by the same sponsor.
- NCT06600282 — Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions · Phase 4 · not yet recruiting
- NCT05654090 — Evaluate Bioequivalence of Burotam (1/1 g/Vial) · Phase 4 · unknown
- NCT05496725 — Evaluate Bioequivalence of Micafungin (50mg/Vial) · Phase 4 · completed
- NCT04552353 — Evaluate Bioequivalence of Voriconazole(200mg/Vial) . · Phase 4 · completed
- NCT05040594 — Evaluate the Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Filler in the Treatment of Nasolabial Folds. · NA · 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 NCT04585412 (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 Yung Shin Pharm. Ind. Co., Ltd.
- Last refreshed: 4 August 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/NCT04585412.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing