Last reviewed · How we verify
NCT03765944
Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets
Phase 1 trial testing sirolimus in Bioequivalence Study in 10 participants. Completed in 29 December 2018.
29 December 2018
Quick facts
| Lead sponsor | Nobelpharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 10 |
| Start date | 5 December 2018 |
| Primary completion | 29 December 2018 |
| Estimated completion | 29 December 2018 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- sirolimus (sirolimus) — full drug profile →
Conditions studied
- Bioequivalence Study — all drugs for Bioequivalence Study →
Sponsor
Nobelpharma — full company profile →
Who can join
Adults 20 to 39, any sex, with Bioequivalence Study. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
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 NCT03765944
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of sirolimus
Trials testing the same drug.
- NCT03866681 — Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH · Phase 4 · unknown
- NCT04161144 — Enhancing Self Regulation Among Smokers · Phase 2 · completed
- NCT03504241 — Tolerance by Engaging Antigen During Cellular Homeostasis · Phase 1 · completed
- NCT03217669 — Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy · Phase 1 · unknown
- NCT02688881 — Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors · Phase 4 · completed
Other Nobelpharma trials
Trials by the same sponsor.
- NCT05480553 — NPC-06 to Pain Associated With Acute Herpes Zoster · Phase 3 · completed
- NCT05495425 — Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC · Phase 3 · completed
- NCT04671472 — Efficacy Confirmation Study of NPC-09 · Phase 3 · completed
- NCT04642950 — A Phase II/III Study of Sargramostim · Phase 2, PHASE3 · completed
- NCT04503863 — An Additional Study of NPC-22 in Healthy Adult Males · 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 NCT03765944 (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 Nobelpharma
- Last refreshed: 25 February 2019
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/NCT03765944.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing