臨床研究等提出・公開システム

Effect of topical steroids application on pharmacokinetics of TW-4752N .

Effect of topical steroids application on pharmacokinetics of TW-4752N .

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Subject were healthy adult male volunteers of Japanese and they were randomly allocated to Group A and B. (Stage in Group A) *StageI >No concomitant medication (Test drug patch applied). *StageII >With concomitant medication (Test drug patch applied after concomitant medication application) (Stage in Group B) *StageI >With concomitant medication (Test drug patch applied after concomitant medication application). *Stage II >No concomitant medication (Test drug patch applied) Age of participants in Group A were 21-43 years old, and Group B participants were 26-43 years old.

Of the 61 volunteers who received screening tests, 57 subjects were selected as eligible. Of these, 41 subjects were hospitalized and 36 were applied by the test drug patch. One subject discontinued treatment during Stage I application due to an adverse event. In addition, one subject was withdrawn due to an adverse event before enrollment in Stage II, and one subject discontinued treatment before Stage II application due to an adverse event. As a result, the test drug patch was attached to 33 subjects during Stage II. Therefore, the number of completed subjects were received the test drug in Stage II was 33.

Adverse events were observed in 21 of 34 subjects (33 cases) without concomitant medication (Test drug patch applied) and in 16 of 35 subjects (18 cases) with concomitant medication (Test drug patch applied after concomitant medication). Of these, without concomitant medication (Test drug patch applied), application site erythema (18 cases), application site itching (10 cases), application site papule (2 cases), vomiting (1 case), headache (1 case), and leukopenia (1 case). And in subjects with concomitant medication (Test drug patch applied after concomitant medication), application site erythema (13 cases) and application site itching (2 cases) were all determined to be causally related to the test drug. Furthermore, fever (1 case), abdominal pain (1 case), and diarrhea (1 case) in subjects receiving concomitant medications (the test drug was applied after the concomitant medication) were determined to be not causally related to the study drug. All of them recovered or improved without any treatment and were judged to clinically insignificant. No serious adverse events or death case occurred.

The study design was appropriate, and as a result of evaluating bioequivalence in 33 subjects in this study, the primary endpoint, AUC96, met the judgement criteria. Therefore, it was concluded that there was bioequivalent between no concomitant medication (test drug patch) and concomitant medication (test drug patch applied after concomitant medication application), and that applying the concomitant medication, Fulmeta(R) Lotion, before applying TW-4752N did not affect the pharmacokinetics of TW-4752N.

Refer to 9 and 10

Mar. 31, 2026

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs041250023

Jun Miura

Sokujinkai kitahiroshima Hospital

6-2-2 Chuo, Kitahiroshima-shi, Hokkaido

miura-j@hus.ac.jp

Masahiro Nakahara

Sokujinkai kitahiroshima Hospital

6-2-2 Chuo, Kitahiroshima-shi, Hokkaido

+81-11-373-5811

m-nakahara@cli-creative.com

Complete

May. 13, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

other

1. Healthy Japanese adult males aged 20 to 45 at the time of obtaining informed consent.
2. Subjects whose BMI is 18.5 or more and less than 25.0 at the time of the screening test (the second decimal position is truncated)
3. A person who are determined by the principal investigator as eligible subjects for the specified clinical study, taking into consideration of the applicant background, physical findings, vital signs, electrocardiogram, and clinical laboratory tests, etc. obtained from the screening test.
4. Subjects who have received sufficient explanation of the study drug/concomitant medication and the purpose and content of this specified clinical study (including subject limitations), and who have given written consent to participate in the study voluntarily.

1. Subjects with myocardial infarction, valvular disease, cardiac diseases such as cardiomyopathy, electrolyte abnormalities (hypokalemia, etc.), or with a history of prolonged QT or its history/family history.
2. Subjects with skin diseases such as eczema, dermatitis, and pigmentary abnormalities.
3. Subjects with low body weight less than 50kg.
4. Subjects with disease currently being treated.
5. Subjects who used other drugs within 1 week before applying the study drug in Phase I.

Male

Healthy adult males

To confirm the effect of TW-4752N on the pharmacokinetics by applying a single TW-4752N (patch containing rivastigmine 51.84mg) to the anterior chest, following the application of the concomitant drug FULMETA Lotion.
Randomisation with or without concomitant medication will be performed in a crossover fashion, with each phase TW-4752N being applied for 3 days.
When applying concomitant medications, the extent of 0.25g should be determined.

AUC96 of unchanged objects in plasma

Cmax, AUC from zero to infinity, tmax, MRT96 and kel of unchanged objects in plasma

+81-561-62-3311

April. 22, 2025

none