Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 1404 for:    Area Under Curve AND tablet

A Bioequivalence Study of Capecitabine Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01846650
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer or Metastatic Colorectal Cancer Drug: Capecitabine tablets Drug: XELODA Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer
Study Start Date : December 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine tablets
Single oral Capecitabine tablets 2000mg qd
Drug: Capecitabine tablets
Single oral Capecitabine tablets 2000mg qd

Active Comparator: XELODA
Single oral XELODA 2000mg qd
Drug: XELODA
Single oral XELODA 2000mg qd




Primary Outcome Measures :
  1. Area Under Curve (AUC) [ Time Frame: predose, 0.33,0.67,1,1.5,2,2.5,3,4,5,6,8,hours post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer,without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients;
  • Age: 18-70 years, gender: both,BMI≥17,Eastern Cooperative Oncology Group (ECOG) performance status:0-2,Life expectancy greater than 3 months;
  • Patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: ANC≥1.5×109/L,PLT≥80×109/L, Total bilirubin≤1.5×the upper limit of normal, ALT,AST≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal.
  • Patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy.
  • Patients must volunteer to participate and sign informed consent form.

Exclusion Criteria:

  • Suffering from heart, liver, kidney disease or severe acute and Organ invasion disease;
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
  • Pregnant or breast-feeding female
  • Only bone metastasis lesions, no other measurable lesions
  • Known brain metastasis or history of organ transplantation
  • Have long-term systemic steroid therapy
  • Serious diseases of vital organs; other malignancies which is not cure
  • Use of chemotherapy in the last 4 weeks
  • History of drug/alcohol addiction or a positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
  • Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
  • Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria or known, existing uncontrolled coagulopathy.
  • Subjects are thought unsuitable for the study by investigators;
  • Inability to comply with protocol or study procedures in the opinion of the investigator;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846650


Locations
Layout table for location information
China, Shanxi
First Affiliated Hospital of Fourth Military Medical University
Xi an, Shanxi, China
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Wen Ai dong, doctor First Affiliated Hospital of Fourth Military Medical University

Layout table for additonal information
Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT01846650     History of Changes
Other Study ID Numbers: KPTB-1.1
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents