Last reviewed · How we verify
NCT03659435
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h)
Phase 1 trial testing RID-TDS 9.5 mg/24 h in Bioequivalence in 58 participants. Completed in 28 November 2018.
28 November 2018
Quick facts
| Lead sponsor | SocraTec R&D GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 58 |
| Start date | 22 August 2018 |
| Primary completion | 28 November 2018 |
| Estimated completion | 28 November 2018 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- RID-TDS 9.5 mg/24 h — full drug profile →
- Exelon® 9.5 mg/24 h — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
SocraTec R&D GmbH — full company profile →
Who can join
Adults 18 to 55, male only, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 9.5 mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch application. Each of both treatments will last for 11 days with a washout period of 14 days between the treatments.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparative Bioavailability Study of a Novel Multi-Day Patch Formulation of Rivastigmine (Twice Weekly) with Exelon® Transdermal Patch (Daily)- A Randomized Clinical Trial.
Schurad B, Koch C, Schug B, Morte A, et al · · 2022 · cited 9× · PMID 36017827 · DOI 10.2174/1567205019666220823105059
Verify or expand the search:
- PubMed search for NCT03659435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bioequivalence
Currently open trials in the same condition.
- NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa · Phase 1 · recruiting
Other SocraTec R&D GmbH trials
Trials by the same sponsor.
- NCT05883124 — Rivastigmine Bioequivalence Trial With Multiple Applications of Transdermal Patches (9.5 mg/24 h) · Phase 1 · completed
- NCT06247410 — Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease · Phase 2 · completed
- NCT04790136 — Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration · Phase 1 · completed
- NCT04505787 — S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet · Phase 1 · completed
- NCT03573050 — Rivastigmine BA Trial With Multiple Application of Transdermal Patches, Adaptation and Tapering Phase · 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 NCT03659435 (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 SocraTec R&D GmbH
- Last refreshed: 19 September 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/NCT03659435.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing