Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-29 @ 8:48 PM
Study NCT ID:
NCT01846650
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of Capecitabine Tablets
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)
2. Experimental Design： Two-period crossover design
3. Test drug: Capecitabine tablets Reference drug: XELODA
4. Sample size：24
2. Experimental Design： Two-period crossover design
3. Test drug: Capecitabine tablets Reference drug: XELODA
4. Sample size：24
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: