HP-1040 Clinical Study

JRCT ID: jRCTs031190145

Registered date:28/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Only healthy subjects
• Date of first enrollment: 27/01/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): The investigational drugs are to be randomly allotted to each arm. And then, each one sheet of HP-1040-4.5 or RIVP-4.5 is to be put on the same part of the body together once per day for successive 9 days. Finally, clinical findings of the part are to be evaluated.

Outcome(s)

• Primary Outcome: Skin irritation score
• Secondary Outcome: Administration Discontinued Rates (%)

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

(1) Japanese healthy adult men and women between 45 and 65 years old at the date of consent
(2) A body mass index (BMI) greater than or equal to 18.5 and less than 25.0 kilogram per square meter (kg/m2)
(3) The person himself / herself has received a thorough explanation of the research drug and the purpose / content of the research, voluntarily volunteered and has agreed in writing to participate in the clinical research

Exclude criteria

(1) Those who have skin diseases and/or skin abnormalities that may hinder evaluation of the scheduled administration site of the study drug. Skin diseases include dermatitis, pigment abnormalities, trauma, etc. Skin abnormalities including eczema, atrophic skin, vulnerable skin, abnormally dry skin, skin tuberculosis, syphilitic skin disease, herpes simplex, (pemphigus vulgaris?) vaccinal eruption, etc.
(2) Those who have no available skin on the scheduled administration site of the study drug due to body hair, and/or have tattoos and moles and/or frequently tan their skin
(3) Those who suffers from atopic dermatitis or have a history of the disease
(4) Those who know that their skin is sensitive to external preparations (including over-the-counter drugs) and adhesive bandages
(5) Those who have a history of hypersensitivity to rivastigmine or carbamate derivatives
(6) Those who have heart disease i.e. sick sinus syndrome or conduction disorders (sinoatrial block, atrioventricular block) or a history of heart disease
(7) Those who have gastric or duodenal ulcer or a history of those diseases
(8) Those who have a history of or those who have a urinary tract obstruction
(9) Those who have seizures such as epilepsy or have a history of seizures
(10) Those who have bronchial asthma or obstructive pulmonary disease or a history of those diseases
(11) Those who have extrapyramidal disorders or a history of the disease
(12) Those who have a history of or have impaired liver function
(13) Those who have received any medication within 1 week prior to study drug administration
(14) Participants who have participated in other clinical studies or trials within 16 weeks before the start of the study drug administration
(15) Those who are pregnant, nursing, possibly pregnant or breastfeeding
(16) Those who do not agree to report a pregnancy during the study and those who do not agree to attend follow-up visits of the mother and child for up to 1 month after birth.
(17) Those who do not agree to use appropriate contraception (use of condoms, pessaries, spermicides, intrauterine devices, oral contraceptives, etc.) from the time consent is obtained until the end of the clinical study
(18) Those who have positive test results for hepatitis C, syphilis or HIV.
(19) Those who cannot abstain from alcohol or smoking during the clinical study participation period
(20) Those who have dementia or disturbance of consciousness considered difficult to perform self-determination
(21)Other persons who are judged to be ineligible for this research by the Principal Investigator or Sub-Investigato

Related Information

• Primary Sponsor: Fukase Hiroyuki
• Source(s) of Monetary Support: Hisamitsu Pharmaceuticai Co.,Inc