Last reviewed · How we verify
NCT05136521
Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions
Phase 1 trial testing Trazodone HCl - new polymer in Healthy in 28 participants. Completed in 19 July 2020.
19 July 2020
Quick facts
| Lead sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 28 |
| Start date | 17 February 2020 |
| Primary completion | 19 July 2020 |
| Estimated completion | 19 July 2020 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Trazodone HCl - new polymer — full drug profile →
- Trazodone HCl - Contramid® — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, 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 NCT05136521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Aziende Chimiche Riunite Angelini Francesco S.p.A trials
Trials by the same sponsor.
- NCT07199543 — Palatability Study of Five Formulations of Benzydamine HCl Lozenges · Phase 1 · completed
- NCT06922175 — REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization · recruiting
- NCT06650631 — The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinica · NA · recruiting
- NCT06773767 — Bioavailability of Trazodone Hydrochloride (New Polymer) vs. Trazodone Hydrochloride Contramid® at Steady-state. · Phase 1 · completed
- NCT05867160 — Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study · active not 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 NCT05136521 (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 Aziende Chimiche Riunite Angelini Francesco S.p.A
- Last refreshed: 29 November 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/NCT05136521.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing