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

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ClinicalTrials.gov Identifier: NCT03659435
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
SocraMetrics GmbH
Information provided by (Responsible Party):
SocraTec R&D GmbH

Brief 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, Germany) after multiple patch application. Each of both treatments will last for 11 days with a washout period of 14 days between the treatments.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: RID-TDS 9.5 mg/24 h Drug: Exelon® 9.5 mg/24 h Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RID-TDS 9.5 mg/24 h
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
Drug: RID-TDS 9.5 mg/24 h
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

Active Comparator: Exelon® 9.5 mg/24 h
11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period
Drug: Exelon® 9.5 mg/24 h
11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period




Primary Outcome Measures :
  1. AUC96-264 [ Time Frame: from 96 to 264 hours after the first patch application ]
    partial area under the plasma concentration vs. time profile for the time interval 96-264 hours

  2. Cmax,96-264 [ Time Frame: from 96 to 264 hours after the first patch application ]
    maximum concentration in plasma during the nominal time interval 96-264 hours

  3. Cmin,96-264 [ Time Frame: from 96 to 264 hours after the first patch application ]
    absolute minimum concentration within the nominal time interval 96-264 hours

  4. Patch adhesion properties [ Time Frame: at 96, 168 and 264 hours after the first Test patch application ]
    lower one-sided 90% confidence limit for the mean of Test


Secondary Outcome Measures :
  1. Skin irritation [ Time Frame: from first patch removal until last patch removal (approx. 9 to 13 days) ]
    frequency of scores for quantification of skin irritation per treatment and time point

  2. Adverse events [ Time Frame: approximately 7 to 12 weeks, through study completion in case of follow-up ]
    descriptive evaluation of frequency and intensity, relationship to the IMP, action taken, outcome, seriousness, period and treatment

  3. inhibition of plasma butyrylcholinesterase (BuChE) [ Time Frame: from first patch application until 24 hours after the last patch removal ]
    % inhibition of BuChE activity in plasma in comparison to baseline



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. sex: male
  2. age: 18-55 years, inclusive
  3. body-mass index2 (BMI): ≥18.5 kg/m² and ≤ 30.0 kg/m²
  4. 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
  5. non-smoker or ex-smoker for at least 1 month
  6. 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

Exclusion Criteria:

  1. 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)
  2. 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)
  3. 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)
  4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  5. Subjects with chronic obstructive or other pulmonary diseases or bronchial asthma
  6. 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
  7. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  8. systolic blood pressure < 90 or >139 mmHg
  9. diastolic blood pressure < 60 or >89 mmHg
  10. heart rate < 50 bpm or > 90 bpm
  11. body weight below 50 kg
  12. QTc interval > 450 ms
  13. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
  14. 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).
  15. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
  16. 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
  17. Skin abnormality (e.g. tattoo or scar) at the application site
  18. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
  19. history of or current drug or alcohol dependence
  20. positive alcohol or drug test at screening examination
  21. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day
  22. subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
  23. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
  24. blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
  25. administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
  26. regular treatment with any systemically available medication
  27. subjects practising top-performance sports (more than 4 x 2 h per week)
  28. subjects suspected or known not to follow instructions
  29. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659435


Locations
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Germany
SocraTec R&D GmbH, Clinical Pharmacology Unit Recruiting
Erfurt, Thüringen, Germany, 99084
Contact: Cornelius Koch, MD    +49-361-60205 ext 67    cornelius.koch@socratec-pharma.de   
Sponsors and Collaborators
SocraTec R&D GmbH
SocraMetrics GmbH

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Responsible Party: SocraTec R&D GmbH
ClinicalTrials.gov Identifier: NCT03659435     History of Changes
Other Study ID Numbers: 1352riv18ct
2018-001570-18 ( EudraCT Number )
C_30410_P1_05 ( Other Identifier: Luye Pharma AG / Luye Supply AG )
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents