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BioequivalencePhase 1NCT03659435

Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h)

A Phase 1 study testing RID-TDS 9.5 mg/24 h and Exelon® 9.5 mg/24 h 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
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
RID-TDS 9.5 mg/24 h and Exelon® 9.5 mg/24 h
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteGermany
Study dates
22 Aug 2018to 28 Nov 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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • sex: male
  • age: 18-55 years, inclusive
  • body-mass index2 (BMI): ≥18.5 kg/m² and ≤ 30.0 kg/m²
  • good state of health as determined by no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination (including vital sign) and/or ECG, as determined by the investigator
  • non-smoker or ex-smoker for at least 1 month
  • 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 ingredient (especially sick sinus syndrome or conduction defects such as sino-atrial block, atrio-ventricular block)
  • existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient (especially predisposition to urinary obstruction and seizures)
  • existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient (especially active gastric or duodenal ulcers or predisposition to these conditions)
  • history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  • Subjects with chronic obstructive or other pulmonary diseases or bronchial asthma
  • 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 patch
Show all 29Show fewer
  • subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  • systolic blood pressure < 90 or >139 mmHg
  • diastolic blood pressure < 60 or >89 mmHg
  • heart rate < 50 bpm or > 90 bpm
  • body weight below 50 kg
  • 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 the IMP 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 the IMP
  • 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 ingredient
  • 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: Open, Randomized, 2-period, 2-sequence, Cross-over Relative Bioavailability Study to Investigate the Pharmacokinetics and to Assess the Bioequivalence of a Rivastigmine Test Patch Formulation 9.5 mg/24 h (Twice Weekly Patch) Compared to the Reference Exelon® 9.5 mg/24 h (Once Daily Patch) Applied for 11 Days

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.

Conditions
Bioequivalence
Being tested
RID-TDS 9.5 mg/24 h, Exelon® 9.5 mg/24 h

What participants receive

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

  • RID-TDS 9.5 mg/24 hDrug

    3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period

  • Exelon® 9.5 mg/24 hDrug

    11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period

Study groups in NCT03659435
Study groupRoleWhat they receive
RID-TDS 9.5 mg/24 hExperimental3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period
Receives: Drug: RID-TDS 9.5 mg/24 h
Exelon® 9.5 mg/24 hActive comparator11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period
Receives: Drug: Exelon® 9.5 mg/24 h

What is being measured

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

  1. AUC96-264

    partial area under the plasma concentration vs. time profile for the time interval 96-264 hours

    Measured: from 96 to 264 hours after the first patch application

  2. Cmax,96-264

    maximum concentration in plasma during the nominal time interval 96-264 hours

    Measured: from 96 to 264 hours after the first patch application

  3. Cmin,96-264

    absolute minimum concentration within the nominal time interval 96-264 hours

    Measured: from 96 to 264 hours after the first patch application

  4. Patch adhesion properties

    lower one-sided 90% confidence limit for the mean of Test

    Measured: at 96, 168 and 264 hours after the first Test patch application

Secondary outcomes (3)

  1. Skin irritation

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

    Measured: from first patch removal until last patch removal (approx. 9 to 13 days)

  2. Adverse events

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

    Measured: approximately 7 to 12 weeks, through study completion in case of follow-up

  3. inhibition of plasma butyrylcholinesterase (BuChE)

    % inhibition of BuChE activity in plasma in comparison to baseline

    Measured: from first patch application until 24 hours after the last patch removal

Timeline

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

  1. First posted6 Sep 2018
  2. Study start22 Aug 2018
  3. Primary completion28 Nov 2018
  4. Study completion28 Nov 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
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659435
Sponsor's protocol ID
1352riv18ct
Other IDs
2018-001570-18, C_30410_P1_05, 2018
Status last verified
Sep 2019
First submitted
28 Aug 2018
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RID-TDS 9.5 mg/24 h and Exelon® 9.5 mg/24 h 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 6 inclusion and 29 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 19 Sep 2019. 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?

AUC96-264 (time frame: from 96 to 264 hours after the first patch application). The study lists 4 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 NCT03659435.

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 19 Sep 2019.

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