Trial Outcomes & Findings for Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers (NCT NCT02631954)
NCT ID: NCT02631954
Last Updated: 2020-03-18
Results Overview
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
Results posted on
2020-03-18
Participant Flow
Subjects who passed the screening were randomized using IWRS before conducting the clinical trail.
Participant milestones
| Measure |
TR Group
Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg
Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once
Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once
|
RT Group
Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)
Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once
Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
healthy subjects aged 19 to 55 yesars were selected.
Baseline characteristics by cohort
| Measure |
TR Group
n=12 Participants
Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg
Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once
Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once
|
RT Group
n=12 Participants
Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)
Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once
Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
0 Participants
n=7 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
0 Participants
n=5 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
12 Participants
n=7 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
24 Participants
n=5 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
0 Participants
n=7 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
0 Participants
n=5 Participants • healthy subjects aged 19 to 55 yesars were selected.
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
Cmax of Voriconazole
|
2433.7 ng/mL
Standard Deviation 2456.9
|
1997.0 ng/mL
Standard Deviation 406.2
|
PRIMARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
AUCt of Voriconazole
|
6966.17 hr*ng/mL
Standard Deviation 2856.10
|
7469.78 hr*ng/mL
Standard Deviation 3125.73
|
SECONDARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
Tmax of Voriconazole
|
1.57 hr
Standard Deviation 0.03
|
1.58 hr
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
AUCinf of Voriconazole
|
8159.24 hr*ng/mL
Standard Deviation 4905.05
|
8631.50 hr*ng/mL
Standard Deviation 4401.54
|
SECONDARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
AUCt/AUCinf
|
0.94 Ratio
Standard Deviation 0.10
|
0.90 Ratio
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
Kel (Elemination Rate Constant)
|
0.10 1/hr
Standard Deviation 0.03
|
0.10 1/hr
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrsThe blood sampleing coleected from the subjects was analyzed and result was obtained.
Outcome measures
| Measure |
Reference
n=23 Participants
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=23 Participants
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
t1/2
|
8.42 hr
Standard Deviation 4.61
|
7.98 hr
Standard Deviation 2.92
|
Adverse Events
Reference
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Test
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference
n=23 participants at risk
Reference: Vfend® IV 200mg drug
* RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I
* TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II
|
Test
n=24 participants at risk
Test: Vorico Injection 200mg(Voriconazole) drug
* RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II
* TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I
|
|---|---|---|
|
Eye disorders
photophobia
|
78.3%
18/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
87.5%
21/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Eye disorders
colour blindness acquired
|
4.3%
1/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
0.00%
0/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Eye disorders
vision blurred
|
8.7%
2/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
0.00%
0/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Eye disorders
visual impariment
|
4.3%
1/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
4.2%
1/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Nervous system disorders
headache
|
0.00%
0/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
8.3%
2/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Investigations
blood glucose increased
|
0.00%
0/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
4.2%
1/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
4.2%
1/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Investigations
urine oxalate increased
|
0.00%
0/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
4.2%
1/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Investigations
white blood cells urine positive
|
4.3%
1/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
0.00%
0/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
4.3%
1/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
0.00%
0/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Vascular disorders
dizziness
|
13.0%
3/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
12.5%
3/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
|
Vascular disorders
epistaxis
|
4.3%
1/23 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
0.00%
0/24 • 1 months
There was no serious AE. A total of 58 AEs out of 24 subjects who took IP more than at least one time, were observed. All of the AEs were mild and recovered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place