UMIN ID: UMIN000056194
Registered date:19/11/2024
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.
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Pain |
| Date of first enrollment | 2024/10/26 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Administer IP-TA to IP-TB Administer IP-TB to IP-TA |
Outcome(s)
| Primary Outcome | Cmax of Ibuprofen Partial AUC0-0.5 of Ibuprofen |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 55years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Any history or presence of clinically relevant disease |
Related Information
| Primary Sponsor | SSP Co, Ltd |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Self-funding |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shiho Yamane |
| Address | 3-20-2 Nishishinjuku Shinjuku-ku, Tokyo Japan 163-1488 |
| Telephone | 0363013422 |
| CHCJPNMed@sanofi.com | |
| Affiliation | SSP Co, Ltd Science Hub, Medical |
| scientific contact | |
| Name | Shunji Matsuki |
| Address | 3-5-1, Kashiiteriha, Higashi-ku, Fukuoka 813-0017 Japan Japan |
| Telephone | 092-662-3608 |
| CHCJPNMed@sanofi.com | |
| Affiliation | SOUSEIKAI Fukuoka Mirai Hospital SOUSEIKAI Fukuoka Mirai Hospital |