A clinical trial to study the bioequivlence study of Capeciatabine in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition
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ABSTRACT: Intervention1: Capecitabine Tablets USP 500 mg: The recommended dose of Capecitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles
Control Intervention1: Xeloda® (capecitabine) Tablets 500 mg: The recommended dose of XELODA® is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Dr. Reddys Laboratories, India) relative to that ofreference formulation (XELODAÂ 500 mg tablets, Manufacturedby Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom) in patients of Locally Advanced or Metastatic Breast Cancer or
Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: NIL
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label
DISEASE(S): Malignant Neoplasm Of Breast Of Unspecified Site
Project description:Intervention1: Capecitabine Tablets USP 500 mg,Each film -coated tablet contains: Capecitabine USP 500 mg,Manufactured by: Intas Pharmaceuticals Limited, India.: The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning
and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest
period given as 3 week cycles
Control Intervention1: Xeloda® (capecitabine) Tablets 500 mg,Each tablet contains: Capecitabine 500 mg,Distributed by: Roche Laboratories Inc., New Jersey 07110: The recommended dose of XELODA® is 1250 mg/m2 administered orally twice daily (morning
and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest
period given as 3 week cycles
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India)] relative to that of reference formulation [Xeloda (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110)] in patients of Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: NIL
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label
Project description:Intervention1: Capecitabine Tablets 500 mg, manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles
Intervention2: Capecitabine Tablets 500 mg,manufactured by Hetero labs
ltd.: The recommended dose of capacitabine is 1250 mg/m2
administered orally twice daily
(morning and evening;
equivalent to 2500 mg/m2 total
daily dose) for 2 weeks followed
by a 1-week rest period given
as 3 week cycles
Control Intervention1: Xeloda (Capecitabine) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080): The recommended dose of
XELODAÂ is 1250 mg/m2
administered orally twice daily
(morning and evening;
equivalent to 2500 mg/m2 total
daily dose) for 2 weeks followed
by a 1-week rest period given
as 3 week cycles
Primary outcome(s): Establishing the bioequivalence between test and referenceTimepoint: Day 1 and Day 2
Project description:Intervention1: Capecitabine Manufactured by Mylan Pharmaceutical Inc., USA: Each patient will receive a Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose)for 14 days. The dose will be comprised of multiples of the 500 mg tablet
Control Intervention1: XELODAÂ (Capecitabine 500 mg) tablets: capecitabine tablets in the doses of 2500 mg/m2/day in two divided dose i.e. in morning and evening
Control Intervention2: XELODAÂ (Capecitabine 500 mg) tablets.: XELODAÂ 500 mg tablets, Manufactured by Genentech US Inc. USA).Each patient will receive a Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose)for 14 days. The dose will be comprised of multiples of the 500 mg tablet.
Primary outcome(s): To characterize the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Mylan Pharmaceutical Inc., USA) relative to that of reference formulation (XELODAÂ 500 mg tablets, Manufactured by Genentech US Inc. USA) in patients of Metastatic Breast Cancer, Dukes C Colon Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
Project description:Intervention1: Capecitabine Tablets USP 500 mg
Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Intas Pharmaceuticals Ltd, India.
: The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles.
In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s.
Control Intervention1: Xeloda (capecitabine) Tablets 500 mg
Each tablet contains: Capecitabine 500 mg
Distributed by: Roche Chemical and Pharmaceutical Products SA, Brazil
: The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s.
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, India)] relative to that of reference formulation [XelodaÂ(capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., Brazil)] in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label
Project description:Intervention1: XELODAÂ -Capecitabine 500 mg tablets: Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days including of three study periods.
Control Intervention1: Capecitabine 500 mg tablets: Capecitabine 1250 mg/m2 administered twice daily orally; BD morning and evening; equivalent to 2500 mg/m2 total daily dose for 14 days including of three study periods.
Primary outcome(s): To characterize the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Cadila Heathcare Limited, India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Manufactured by Genentech USA Inc. USA) in patients of Metastatic Breast Cancer, Dukes C Colon Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: Time points are 30 minutes prior to drug dosing and at 0.25hr, 0.50hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 5hr, 6hr, 8hr and 10 hours post-dose.
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
Project description:Intervention1: Capecitabine Tablets USP 500 mg: Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Dr. Reddys Laboratories, India
The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles.
In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be reference listed drug Xeloda (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) and doses for the remainder treatment cycle will be locally approved and marketed drug.
The morning and evening dose will be based on BSA. The BSA will be calculated for the patient 12 hours prior to dosing on Day 1 and the same will be used for the dosing on Day 2 as well.
Control Intervention1: Xeloda (capecitabine) Tablets 500 mg: Each tablet contains: Capecitabine 500 mg
Distributed by: Roche Laboratories Inc., New Jersey 07110-1199
The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles.
In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be reference listed drug Xeloda (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) and doses for the r
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Dr. Reddys Laboratories, India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Distributed by Roche Laboratories Inc., USA) in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Other Method of allocation concealment:Centralized Blinding and masking:Open Label
Project description:Intervention1: Capecitabine Extended Release Capsules 500 mg of Intas Pharmaceuticals Limited, India: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week
Control Intervention1: Capecitabine film coated tablets 500 mg of Accord healthcare Inc, USA: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week
Primary outcome(s): To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsors formulation- Capecitabine Extended Release Capsules 500 mg (Test drug, Intas Pharmaceuticals Ltd., India) with Capecitabine) film coated Tablets 500 mg (Reference drug, Intas Pharmaceuticals Ltd., IndiaTimepoint: Pre-dose (Day01, Day 05 to Day 07 and Day 08 Day 12 to Day 14)
Post-dose on Day 07 and Day 14
Project description:Intervention1: Capecitabine Tablets 500 mg, manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles
Control Intervention1: Xeloda (Capecitabine) 500mg film coated tablet, manufactured by Roche Pharma AG, Emil-Barell Str I, D-79639 Grenzach-Wyhlen, Duitsland: The recommended dose of XELODA is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles
Primary outcome(s): Establishing the bioequivalence between test and referenceTimepoint: Day 1 and Day 2
Project description:Intervention1: Capecitabine (CJSC Biocad) tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Capecitabine will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast).
Control Intervention1: Xeloda (Capecitabine)tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Xeloda will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast).
Primary outcome(s): Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug:
Area under capecitabine «concentration-time» curve at the time of the drug administration up to 12 hours (AUC(0-12))
Timepoint: 0 min, 15 mins, 30 mins, 45 mins, 1hr, 1hr 30 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 10 hrs and 12 hrs after administration of the test or reference drug.
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label