Trial Outcomes & Findings for Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body (NCT NCT01795716)
NCT ID: NCT01795716
Last Updated: 2015-05-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
Results posted on
2015-05-19
Participant Flow
Participant milestones
| Measure |
Mesylate Imatinib Capsule First, Then Glivec
Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
|
Glivec First, Then Mesylate Imatinib Capsule
Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
|
|---|---|---|
|
First Intervention (13 Days)
STARTED
|
10
|
11
|
|
First Intervention (13 Days)
COMPLETED
|
10
|
11
|
|
First Intervention (13 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (10 Days)
STARTED
|
10
|
11
|
|
Washout (10 Days)
COMPLETED
|
10
|
11
|
|
Washout (10 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (13 Days)
STARTED
|
10
|
11
|
|
Second Intervention (13 Days)
COMPLETED
|
10
|
11
|
|
Second Intervention (13 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Baseline characteristics by cohort
| Measure |
Mesylate Imatinib Capsule First, Then Glivec
n=10 Participants
Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
|
Glivec First, Then Mesylate Imatinib Capsule
n=11 Participants
Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
n=5 Participants
|
33 years
n=7 Participants
|
33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-doseOutcome measures
| Measure |
Mesylate Imatinib Capsule
n=21 Participants
Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
|
Glivec
n=21 Participants
Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
|
|---|---|---|
|
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
|
37256 mcg*hr/mL
Standard Deviation 11442
|
37206 mcg*hr/mL
Standard Deviation 10620
|
Adverse Events
Mesylate Imatinib Capsule
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Glivec
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mesylate Imatinib Capsule
n=21 participants at risk
Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
|
Glivec
n=21 participants at risk
Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
|
|---|---|---|
|
Gastrointestinal disorders
nausea and vomit
|
47.6%
10/21 • Number of events 10 • 29 days
|
61.9%
13/21 • Number of events 13 • 29 days
|
Additional Information
Dr. Zhou Li
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Phone: 13816510379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place