Clinical Trials Logo

Clinical Trial Summary

The present clinical trial will be conducted to compare the bioavailability of rivastigmine and assess bioequivalence at steady-state of the Test product RIV-TDS 13.3 mg/24 h and the marketed Reference product Exelon® 13.3 mg/24 hours transdermal patch after multiple patch application. Each of both treatments will last 5 days.


Clinical Trial Description

This will be a single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, cross-over trial with multiple applications of rivastigmine transdermal patches. There will be no wash-out, i.e. the first investigational patch application of the second study period will take place the day of the last investigational patch removal of the first study period (direct switch-over).

Prior to start of first treatment, there will be an adaptation phase with 4 consecutive applications of Exelon® 9.5 mg/24 hours transdermal patch over a period of 4 days (each patch will be applied for 24 hours). Following the removal of the last investigational patch in period II, there will be a post-treatment tapering phase with 2 consecutive applications of Exelon® 9.5 mg/24 hours transdermal patch over a period of 2 days (each patch will be applied for 24 hours).

Furthermore, during the adaptation phase, both study periods and the tapering phase, scopolamine transdermal patches will be applied as co-medication to attenuate effects of rivastigmine and reduce Adverse Events. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03573050
Study type Interventional
Source SocraTec R&D GmbH
Contact
Status Completed
Phase Phase 1
Start date May 16, 2018
Completion date July 5, 2018

See also
  Status Clinical Trial Phase
Completed NCT03705533 - Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State Phase 1
Completed NCT04938856 - Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions Phase 1
Completed NCT03646331 - Bioequivalence of Imeglimin Tablet Formulations Phase 1
Completed NCT04564456 - A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05197517 - Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition Phase 1
Completed NCT03702894 - Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions Phase 1
Completed NCT03018015 - Ibuprofen Bioavailability Trial With Oral Single Dose Administration. Phase 1
Withdrawn NCT02894515 - Bioequivalence Study of Idalopirdine in Healthy Subjects Phase 1
Completed NCT02206295 - Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg Phase 1
Completed NCT01331993 - A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation Phase 1
Completed NCT01260805 - A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers. Phase 1
Recruiting NCT06066112 - Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body Phase 1
Completed NCT05477810 - Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions Early Phase 1
Completed NCT04546256 - A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05083325 - Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product Phase 1
Completed NCT05061901 - Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions Phase 1
Recruiting NCT04138888 - A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions Phase 1
Completed NCT05145621 - Oral Bio-equivalence Study Phase 1
Completed NCT06124560 - Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. Phase 1
Completed NCT03340753 - Bioavailability of KBP-5074 Tablet vs Capsule Formulations Phase 1