Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer
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ABSTRACT:
DISEASE(S): Patient Participation
PROVIDER: 2341726 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Intervention1: Capecitabine 500 mg Tablet of Sun
Pharmaceutical Industries Limited, India
: Single Oral Dose
Control Intervention1: PrXeloda (Capecitabine) 500 mg Tablet of
Hoffmann-La Roche Limited, 2455 Meadowpine Blvd, Mississauga,
Ontario, L5N 6L7
: Single Oral Dose
Primary outcome(s): 1) To characterize the rate and extent of
bioavailability of the test products in comparison
with the reference product after single dose
Administration under fed conditions.
2) Monitor the safety of the subjects participating
in the study and the tolerability of the test
products in comparison with the reference
Considering adverse events.
Timepoint: Pre Dose samples: 6 ml will be collected within 1.0 hour
Prior to morning dosing.
Post Dose samples:
The post-dose blood samples (1 x 2 mL each) will be collected
at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000,
2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of
Morning dose.
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Open Label
| 2574844 | 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
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
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: 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
| 2573937 | ecrin-mdr-crc
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
| 2573271 | ecrin-mdr-crc
Project description: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
| 2144279 | ecrin-mdr-crc
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:The dispersible tablet formulation (DTF) of pretomanid has been developed to facilitate future use in children. This work aimed to assess the pharmacokinetics (PK) and relative bioavailability of the DTF compared to the marketed formulation (MF) and the potential influence of dose. Pretomanid DTF was investigated in a single-dose, randomized, four-period, cross-over study, with 7 days of washout between doses. Forty-eight healthy volunteers were enrolled and randomized into one of two panels to receive doses either in the fasted state or after a high-fat meal. Each volunteer received doses of 10, 50, and 200 mg DTF, and 200 mg MF pretomanid. Blood samples for pharmacokinetic assessment were drawn following a rich schedule up to 96 h after each single dose. The study data from the panel receiving the high-fat meal were analyzed using a nonlinear mixed-effects modeling approach, and all data were characterized with noncompartmental methods. A one-compartment model with first-order elimination and absorption through a transit compartment captured the mean and variability of the observed pretomanid concentrations with acceptable precision. No significant difference in bioavailability was found between formulations. The mean absorption time for the DTF was typically 137% (86-171%) of that for the MF. The bioavailability was found to be dose dependent with a small positive and larger negative correlation under fed and fasted conditions, respectively. Using data from a relative bioavailability study in healthy adult volunteers, a mathematical model has been developed to inform dose selection for the investigation of pretomanid in children using the new dispersible tablet formulation. Under fed conditions and at the currently marketed adult dose of 200 mg, the formulation type was found to influence the absorption rate, but not the bioavailability. The bioavailability of the DTF was slightly positively correlated with doses when administered with food. ClinicalTrials.gov Identifier: NCT04309656, first posted on 16 March 2020.
| S-EPMC9524735 | biostudies-literature
Project description:Background and objectivesTicagrelor is an antiplatelet agent for patients with acute coronary syndrome or a history of myocardial infarction. Two studies compared pharmacokinetic profiles of orodispersible (OD) ticagrelor tablets versus immediate-release (IR) tablets in Western and Japanese subjects.MethodsBoth studies were open-label, randomized, crossover, single-center trials. Thirty-six healthy subjects (94% white, 6% other race; Western study NCT02400333) and 42 Japanese healthy subjects (Japanese study NCT02436577) received a single 90-mg ticagrelor dose as an OD tablet [with/without water, and via a nasogastric tube (Western study only)], and an IR tablet; washout between treatments was ≥7 days. Assessments included ticagrelor and AR-C124910XX (active metabolite) plasma concentrations for pharmacokinetic analyses, and safety evaluations.ResultsIn the Western study, the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for ticagrelor and AR-C124910XX maximum plasma concentration (C max) and area under the plasma concentration-time curve (AUC) were within the acceptance interval (80%-125%) for OD tablets (with/without water, via a nasogastric tube) versus the IR tablet; except for an ~15% lowering of ticagrelor C max (90% CI: 76.77%-93.78%) for the OD tablet taken with water. In the Japanese study, 90% CIs of the GMRs for AUC and C max of both ticagrelor and AR-C124910XX were all within the acceptance intervals for the OD (with/without water) versus IR tablet. No new safety issues were identified.ConclusionsTicagrelor administered as an OD tablet to Western (without water, and via a nasogastric tube) and Japanese (with/without water) subjects was bioequivalent to the IR tablet.
| S-EPMC5643369 | biostudies-literature