Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT03435666
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of Capecitabine Tablets 500 mg in Adult Cancer Patients Under Fed Condition
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Reference Replicate Crossover, Single Dose, Bioequivalence Fed Study of Capecitabine Tablets in Comparison With XELODA in Adult Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
NOT_YET_RECRUITING
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:
Capecitabine
Brief Summary:
Purpose: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc.
Design: two treatment, three period, three sequence, reference replicate crossover, single dose.
Test Drug: Capecitabine Tablets; Reference drug: XELODA Sample size: Around 45 patients will be enrolled to have at least 39 evaluable patients in the study.
Design: two treatment, three period, three sequence, reference replicate crossover, single dose.
Test Drug: Capecitabine Tablets; Reference drug: XELODA Sample size: Around 45 patients will be enrolled to have at least 39 evaluable patients in the study.
Detailed Description:
Objectives:
Primary Objective: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc. following a single oral dose administration in adult cancer patients under fed condition.
Secondary Objective: To monitor the safety and tolerability profile of the subjects exposed to the Investigational Medicinal Product.
Study Design: a randomized, multicenter, open label, balanced, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study under fed conditions.
Number of subjects: at least 39 evaluable patients Mode of Administration for Test and Reference product: Patient will be randomized to one of the three treatment sequences i.e. TRR, RTR or RRT. Where T-Test drug and R-Reference drug. The study medication will be administered in the morning of Day 1 (Period I of the study), Day 2(Period II of the study) and Day 3 (Period III of the study).
Since, the patients are on a twice daily dosing regimen the patients should receive their usual dose of capecitabine as per their dosing regimen between each subsequent study periods. The drug product used to administer the dose between the study periods can be the same or any approved product as that used by the patients for their current dosing regimen. The morning and evening doses will be based on BSA.
Blood collection times: pre-dose blood sample of 03 mL (00.00) will be collected within 5 minutes before dosing in each period of the study. After dosing in each period (Day 1, Day 2 and Day 3), the post-dose blood samples of 03mL each will be drawn at 0.17 (10min), 0.33 (20min), 0.50 (30 min),0.67 (40min), 0.83 (50min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours following drug administration.
Bioequivalence Criteria:
For Capecitabine, the bioequivalence will be concluded based on within-subject standard deviation of reference formulation, termed as SWR.
Reference - Scale Average Bioequivalence Approach:
When SWR ≥ 0.294 for any of the primary pharmacokinetic parameters, below mentioned both the criteria must be satisfied: The 95% upper confidence bound for (μT- μR)2/S2WR determined must be ≤ θ, or equivalently, a 95% upper confidence bound for (μT- μR)2-θ\*S2WR must be ≤ 0; and the point estimate (test/reference geometric mean ratio) must fall within \[0.80, 1.25\].
Conventional Average Bioequivalence Approach:
When SWR \< 0.294 for any of the primary pharmacokinetic parameters, 90% confidence interval for the geometric least square means ratio (T/R) of that parameter must be fall within the acceptance range of 80.00% to 125.00%.
Primary Objective: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc. following a single oral dose administration in adult cancer patients under fed condition.
Secondary Objective: To monitor the safety and tolerability profile of the subjects exposed to the Investigational Medicinal Product.
Study Design: a randomized, multicenter, open label, balanced, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study under fed conditions.
Number of subjects: at least 39 evaluable patients Mode of Administration for Test and Reference product: Patient will be randomized to one of the three treatment sequences i.e. TRR, RTR or RRT. Where T-Test drug and R-Reference drug. The study medication will be administered in the morning of Day 1 (Period I of the study), Day 2(Period II of the study) and Day 3 (Period III of the study).
Since, the patients are on a twice daily dosing regimen the patients should receive their usual dose of capecitabine as per their dosing regimen between each subsequent study periods. The drug product used to administer the dose between the study periods can be the same or any approved product as that used by the patients for their current dosing regimen. The morning and evening doses will be based on BSA.
Blood collection times: pre-dose blood sample of 03 mL (00.00) will be collected within 5 minutes before dosing in each period of the study. After dosing in each period (Day 1, Day 2 and Day 3), the post-dose blood samples of 03mL each will be drawn at 0.17 (10min), 0.33 (20min), 0.50 (30 min),0.67 (40min), 0.83 (50min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours following drug administration.
Bioequivalence Criteria:
For Capecitabine, the bioequivalence will be concluded based on within-subject standard deviation of reference formulation, termed as SWR.
Reference - Scale Average Bioequivalence Approach:
When SWR ≥ 0.294 for any of the primary pharmacokinetic parameters, below mentioned both the criteria must be satisfied: The 95% upper confidence bound for (μT- μR)2/S2WR determined must be ≤ θ, or equivalently, a 95% upper confidence bound for (μT- μR)2-θ\*S2WR must be ≤ 0; and the point estimate (test/reference geometric mean ratio) must fall within \[0.80, 1.25\].
Conventional Average Bioequivalence Approach:
When SWR \< 0.294 for any of the primary pharmacokinetic parameters, 90% confidence interval for the geometric least square means ratio (T/R) of that parameter must be fall within the acceptance range of 80.00% to 125.00%.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: