A Bioequivalence Study of Capecitabine Tablets
Ontology highlight
ABSTRACT:
DISEASE(S): Metastatic Breast Cancer Or Metastatic Colorectal Cancer,Colorectal Neoplasms,Breast Neoplasms
PROVIDER: 2144279 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Intervention1: Capecitabine tablets 500 mg: In the current study, patients will be administered 3 tablets of Capecitabine 500 mg (Test Product or Reference Product) as the morning dose on first day of each period. The evening dose on Day 1 and next 13 days dosing will be as per the discretion of the investigator
Control Intervention1: XELODA® 500 mg tablets: In the current study, patients will be administered 3 tablets of Capecitabine 500 mg (Test Product or Reference Product) as the morning dose on first day of each period. The evening dose on Day 1 and next 13 days dosing will be as per the discretion of the investigator.
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsor?s test formulation (Capecitabine Tablets 500 mg, Manufactured by Intas Pharmaceutical Ltd., India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Manufactured by Roche Pharma AG, Germany) in patients of Locally Advanced or Metastatic Breast 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:Permuted block randomization, variable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
| 2572055 | ecrin-mdr-crc
Project description:Intervention1: Capecitabine Extended Release Capsule 500 mg
(Intas Pharma)
: Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week
Control Intervention1: Xeloda (Capecitabine) film coated tablets
500 mg
(Roche Pharmaceuticals)
: Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week
Primary outcome(s): AUCTimepoint: Day 07 and Day 14
| 2577537 | ecrin-mdr-crc
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
| 2572297 | ecrin-mdr-crc
Project description: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
| 2573103 | ecrin-mdr-crc
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
| 2573796 | ecrin-mdr-crc
Project description:Intervention1: Capecitabine Tablets 500mg: Capecitabine Tablets 500
mg will be administered as a single oral dose as multiples of 500mg on Day 1 and
Day 2 morning dose as per randomization schedule.
Control Intervention1: Xeloda tablet 500mg: Capecitabine Tablets 500 mg will be administered as a single oral dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule.
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation
[Capecitabine Tablets 500 mg] relative to that of reference formulation [Xeloda Tablets 500 mg] in patients with
Metastatic Breast Cancer or Colorectal Cancer under fed condition and to
assess the bioequivalence.Timepoint: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5,
6, 8, 10 hr post-dose in each period administration
| 2573902 | ecrin-mdr-crc
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
| 2582199 | ecrin-mdr-crc
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
| 2573184 | ecrin-mdr-crc
Project description:Intervention1: Capecitabine Tablets
: Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
Control Intervention1: Capecitabine (Xeloda) Tablets: Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
Primary outcome(s): Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters:
â?¢Cmax
â?¢AUC0tTimepoint:
â?¢D1, D3, D5
â?¢D1, D3, D5
Study Design: Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
| 2573355 | ecrin-mdr-crc
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
| 2573458 | ecrin-mdr-crc