AzTrials
AzTrials

BioequivalencePhase 1NCT03573050

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

A Phase 1 study testing RIV-TDS 13.3 mg/24 h and Exelon® 13.3 mg/24 hours transdermal patch in people with Bioequivalence, run by SocraTec R&D GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
RIV-TDS 13.3 mg/24 h and Exelon® 13.3 mg/24 hours transdermal patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteGermany
Study dates
16 May 2018to 5 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sex: male
  • Ethnic origin: Caucasian
  • Age: 18 - 50 years, inclusive
  • Body-mass index2 (BMI): >=18.5 kg/m² and <= 30.0 kg/m²
  • Good state of health
  • Non-smoker or ex-smoker for at least 6 months
  • Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Who cannot join

  • Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredients (especially sick sinus syndrome or conduction defects such as sino-atrial block, atrio-ventricular block, arrhythmia, bradycardia)
  • Existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredients (especially predisposition to urinary obstruction and seizures or other conditions with difficulty in passing water owing to an impeded flow of urine (e.g. in diseases of the prostate))
  • Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredients (especially active gastric or duodenal ulcers or predisposition to these conditions, pyloric stenosis, intestinal obstruction)
  • History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders (e.g. cerebral sclerosis)
  • History of asthma or obstructive pulmonary disease
  • Glaucoma or any indications from case history that there might be raised intra-ocular pressure (e.g. pressure pain, blurred vision, glaucomatous halo)
Show all 30Show fewer
  • Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations or previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine or scopolamine patch
  • Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  • Body weight below 65 kg
  • Systolic blood pressure < 90 or ≥ 140 mmHg
  • Diastolic blood pressure < 60 or >90 mmHg
  • Heart rate < 60 bpm or > 90 bpm
  • QTc interval > 450 ms
  • Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
  • ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 μmol/l ULN).
  • Positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
  • Presence or history of acute or chronic diseases especially of the skin, which could affect dermal absorption or metabolism, which may interfere with the bioavailability and /or the pharmacokinetics of scopolamine or rivastigmine patches based on assessment of the investigator
  • Skin abnormality (e.g. tattoo or scar) at the application site
  • Acute or chronic diseases which may interfere with the pharmacokinetics of scopolamine or rivastigmine patches
  • History of or current drug or alcohol dependence
  • Positive alcohol or drug test at screening examination
  • Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day
  • Subjects who are on a diet which could affect the pharmacokinetics of the active ingredients
  • Regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
  • Blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
  • Administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
  • Regular treatment with any systemically available medication
  • Subjects practising top-performance sports (more than 4 x 2 h per week)
  • Subjects suspected or known not to follow instructions
  • Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial -

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • SocraTec R&D GmbH, Clinical Pharmacology Unit

    Erfurt, Thuringia, 99084

Other trials in Germany

About this study

Official title: Multiple Dose Crossover Comparative Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared With Exelon® Transdermal Patch With a Release Rate of 13.3 mg/24 Hours in Healthy Male Subjects With Preceding Adaptation Phase and Post-treatment Tapering Phase

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.

Read the detailed 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.

Conditions
Bioequivalence
Being tested
RIV-TDS 13.3 mg/24 h, Exelon® 13.3 mg/24 hours transdermal patch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RIV-TDS 13.3 mg/24 hDrug

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

  • Exelon® 13.3 mg/24 hours transdermal patchDrug

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

Study groups in NCT03573050
Study groupRoleWhat they receive
RIV-TDS 13.3 mg/24 h (Test)Experimental5 consecutive patch applications of Test (each patch to be applied for 24 hours)
Receives: Drug: RIV-TDS 13.3 mg/24 h
Exelon® 13.3 mg/24 hours transdermal patch (Reference)Active comparator5 consecutive patch applications of Reference (each patch to be applied for 24 hours)
Receives: Drug: Exelon® 13.3 mg/24 hours transdermal patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-tau,ss

    Area under the plasma concentration vs. time curve at steady state for rivastigmine

    Measured: from 0 to 24 hours following the 5th patch application

  2. Ctau,ss

    (Trough) minimum plasma concentration at the end of the dosing interval at steady state for rivastigmine

    Measured: from 0 to 24 hours following the 5th patch application

  3. Cmax,ss

    Maximum plasma concentration within the dosing interval at steady state for rivastigmine

    Measured: from 0 to 24 hours following the 5th patch application

Secondary outcomes (3)

  1. Patch adhesion

    one-sided lower 90% confidence limit of mean adherence percentage at the end of the dosing interval of the 5th patch

    Measured: from first investigational patch application until removal of the last investigational patch (approx. 10 days)

  2. Skin irritation

    frequency of scores for quantification of skin irritation per treatment and time point

    Measured: from first investigational patch removal until last investigational patch removal (approx. 10 days)

  3. Adverse events

    descriptive evaluation of frequency and intensity, relationship to the IMP, action taken, outcome, seriousness, period and treatment

    Measured: approximately 2 weeks, through study completion in case of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start16 May 2018
  3. Primary completion5 Jul 2018
  4. Study completion5 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573050
Sponsor's protocol ID
1351riv18ct
Other IDs
2018-000968-28, C_30170_P1_16, 2018
Status last verified
Aug 2018
First submitted
22 May 2018
Last updated
21 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Morte A, Vaque A, Iniesta M, Schug B, Koch C, De la Torre R, Schurad B. Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared with Exelon in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2022 Jul;47(4):567-578. doi: 10.1007/s13318-022-00778-5. Epub 2022 Jun 13.

    PubMed 35696054

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RIV-TDS 13.3 mg/24 h and Exelon® 13.3 mg/24 hours transdermal patch in people with Bioequivalence, run by SocraTec R&D GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-tau,ss (time frame: from 0 to 24 hours following the 5th patch application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in