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Rivastigmine BA Trial With Multiple Application of Transdermal Patches, Adaptation and Tapering Phase

NCT03573050 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-08-21

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

RIV-TDS 13.3 mg/24 h

5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours

DRUG

Exelon® 13.3 mg/24 hours transdermal patch

5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours

Sponsors & Collaborators

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-16
Primary Completion
2018-07-05
Completion
2018-07-05

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573050 on ClinicalTrials.gov