Achievements
Phase I Studies
| Study Type | No. of Protocols |
|---|---|
| Single Dose | 507 |
| Multiple Dose | 330 |
| BE | 224 |
| BA | 46 |
| Patch Test | 22 |
| Others | 3 |
| TOTAL | 1,132 |
(Apr 2010)
Phase II - IV
| Study Type | No. of Protocols |
|---|---|
| Early Phase II | 64 |
| Late Phase II | 81 |
| Phase III - IV | 151 |
| PK / PD | 33 |
| Others | 14 |
| TOTAL | 343 |
(Apr 2010)
Achievements by Indications since 1995
| Therapeutic Areas & Indications | No. of Protocols | No. of Subjects | |
|---|---|---|---|
| Internal Medicine | Hypertension | 59 | 3,048 |
| Dyslipidemia | 18 | 661 | |
| Hyperuricemia | 6 | 125 | |
| Diabetes | 78 | 1,603 | |
| Obesity | 7 | 160 | |
| Ophthalmology | Seasonal Conjunctivitis | 11 | 827 |
| Glaucoma | 20 | 677 | |
| Dry Eye | 10 | 221 | |
| Urology | Incontinence | 7 | 290 |
| Dysuria | 1 | 62 | |
| Otolaryngology | Seasonal Allergic Rhinitis | 21 | 3,280 |
| Perennial Allergic Rhinitis | 7 | 1,150 | |
| Respiratory | Acute Upper Respiratory Inflammation | 2 | 40 |
| Bronchial Asthma | 8 | 97 | |
| Dialysis | 30 | 333 | |
| Others | 58 | 2,010 | |
| TOTAL | 343 | 14,584 | |
(Apr 2010)
PK/PD Stuides since 2006
| Indications | No. of Subjects | Study Site | Study Period | |
|---|---|---|---|---|
| Mar 2010 | Hepatitis C | 6 1 |
OCROM (Osaka) ToCROM (Tokyo) |
(3days 2nts) x2 day visitx15 |
| Feb 2010 | Diabetes | 30 36 |
OCROM (Osaka) Koganeibashi (Tokyo) |
(3days 2nts) x2 day visitx4 |
| Sept 2009 | Dyslipidemia | 60 60 |
OCROM (Osaka) ToCROM (Tokyo) |
(2days 1nt) x2 day visitx6 |
| Apr 2009 | Hypertriglyceridemia | 30 | OCROM (Osaka) | (4days 3nts) x2 |
| Apr 2009 | Diabetes | 25 15 |
OCROM (Osaka) Koganeibashi (Tokyo) |
(5days 4nts) + (6days 5nts) + day visitx8 |
| Oct 2008 | Diabetes | 10 | OCROM (Osaka) | (2days 1nt) x2 + day visit x15 |
| Sept 2008 | Glaucoma | 9 | Koganeibashi (Tokyo) | (2days 1nt) x3 + day visit |
| Aug 2008 | Diabetes | 15 15 |
OCROM (Osaka) ToCROM (Tokyo) |
(10days 9nts) + (6days 5nts) + day visit x4 |
| Aug 2008 | Allergic Rhinitis | 36 | Koganeibashi (Tokyo) | (3days 2nts) x6 + day visit x16 |
| Jun 2008 | Hypertension | 14 | OCROM (Osaka) | (3days 2nts) x4 + day visit x5 |
| Jan 2008 | Diabetes | 14 | OCROM (Osaka) | (3days 2nts) + day visit x2 |
| Jan 2008 | Hypertension | 18 | OCROM (Osaka) | (3days 2nts) x4 + day visit x2 |
(Apr 2010)
GCP Inspection Record since 2000
| Inspection Date | Site of Inspection | Study Type | Inspector |
|---|---|---|---|
| Dec 2009 | OPHAC Hospital (Osaka) | PⅡa | PMDA |
| June 2009 | OCROM (Osaka) | PIV | PMDA |
| May 2008 | An affiliated clinic | PIIb | PMDA |
| April 2008 | OPHAC Hospital (Osaka) | PI | PMDA |
| Sept 2007 | ToCROM (Tokyo) | PIII | PMDA |
| Feb 2007 | OPHAC Hospital (Osaka) | PI | PMDA |
| Mar 2004 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Feb 2004 | An affiliated clinic | PIII | PMDA |
| Aug 2003 | An affiliated clinic | PIIb | PMDA |
| July 2003 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Jan 2003 | OPHA (former OCROM; Osaka) | PI | PMDA |
| July 2003 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Jan 2003 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Nov 2002 | An affiliated clinic | PIIb | PMDA |
| Sept 2002 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Oct 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
| Sept 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
| July 2001 | OPHA (former OCROM; Osaka) | PI | PMDA |
(Apr 2010)