UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056194 |
|---|---|
| Receipt number | R000064209 |
| Scientific Title | 2-treament, 2-period, 2-sequence crossover study to compare the pharmacokinetic profile of IP-TA and IP-TB |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2025/05/22 16:07:59 |
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Basic information
Public title
Open-label, randomized, 2-treament, 2-period, 2-sequence crossover study to compare the pharmacokinetic profile of IP-TA and IP-TB in Japanese healthy volunteers.
Acronym
2-treament, 2-period, 2-sequence crossover study to compare the pharmacokinetic profile of IP-TA and IP-TB
Scientific Title
2-treament, 2-period, 2-sequence crossover study to compare the pharmacokinetic profile of IP-TA and IP-TB
Scientific Title:Acronym
2-treament, 2-period, 2-sequence crossover study to compare the pharmacokinetic profile of IP-TA and IP-TB
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Medicine in general | Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the pharmacokinetic profile of IP-TA
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cmax of Ibuprofen
Partial AUC0-0.5 of Ibuprofen
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer IP-TA to IP-TB
Interventions/Control_2
Administer IP-TB to IP-TA
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese volunteer
Key exclusion criteria
Any history or presence of clinically relevant disease
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Matsuki |
Organization
SOUSEIKAI Fukuoka Mirai Hospital
Division name
SOUSEIKAI Fukuoka Mirai Hospital
Zip code
813-0017
Address
3-5-1, Kashiiteriha, Higashi-ku, Fukuoka 813-0017 Japan
TEL
092-662-3608
CHCJPNMed@sanofi.com
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Yamane |
Organization
SSP Co, Ltd
Division name
Science Hub, Medical
Zip code
163-1488
Address
3-20-2 Nishishinjuku Shinjuku-ku, Tokyo
TEL
0363013422
Homepage URL
CHCJPNMed@sanofi.com
Sponsor or person
Institute
SSP Co, Ltd
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakata clinic, Clinical Trial Review Board
Address
6-18 Tenyamachi Hakata-ku Fukuoka-shi, Fukuoka
Tel
0922837701
NA
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Ibuprofen Cmax in IP-TA was approximately 1.7 times higher than in IP-TB (Mean ratio: 1.667; 90% CI: 1.520-1.828)-exceeding the expected increase based on the dose ratio (1.2).
Absorption rate constant (Ka) for ibuprofen was significantly higher in IP-TA than in IP-TB (7.309 vs. 3.322 [1/hr]), further supporting faster absorption.
For acetaminophen, the plasma concentration profiles were comparable between IP-TA and IP-TB, with IP-TA showing a higher Cmax, consistent with the dose ratio.
Results date posted
| 2025 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064209
