Trial Outcomes & Findings for A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects (NCT NCT02704702)
NCT ID: NCT02704702
Last Updated: 2018-11-02
Results Overview
This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
Sequence 1 (ABC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 2 (ACB)
Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 3 (BAC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 4 (BCA)
Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 5 (CAB)
Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 6 (CBA)
Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
5
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Sequence 2 (ACB)
n=6 Participants
Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 3 (BAC)
n=6 Participants
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 1 (ABC)
n=6 Participants
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 4 (BCA)
n=6 Participants
Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 5 (CAB)
n=6 Participants
Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Sequence 6 (CBA)
n=6 Participants
Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
Fimasartan
Rosuvastatin
Fimasartan + Rosuvastatin
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each periodThis Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
Outcome measures
| Measure |
Treatment A(Single Dose)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment A(Multiple Dose)
n=32 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Single Dose)
n=35 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Multiple Dose)
n=32 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose_Fimasartan)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose_Rosuvastatin)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose_Fimasartan)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose_Rosuvastatin)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve
|
690.43 ng*hr/mL
Interval 645.39 to 809.51
|
820.86 ng*hr/mL
Interval 757.5 to 980.63
|
86.442 ng*hr/mL
Interval 82.21 to 105.59
|
114.55 ng*hr/mL
Interval 106.95 to 138.5
|
702.20 ng*hr/mL
Interval 653.05 to 830.43
|
85.078 ng*hr/mL
Interval 78.638 to 115.45
|
880.19 ng*hr/mL
Interval 819.63 to 1018.7
|
98.957 ng*hr/mL
Interval 91.971 to 120.5
|
PRIMARY outcome
Timeframe: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each periodThis Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.
Outcome measures
| Measure |
Treatment A(Single Dose)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment A(Multiple Dose)
n=32 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Single Dose)
n=35 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Multiple Dose)
n=32 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose_Fimasartan)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose_Rosuvastatin)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose_Fimasartan)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose_Rosuvastatin)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration
|
289.12 ng/mL
Interval 272.28 to 373.86
|
362.14 ng/mL
Interval 339.1 to 523.63
|
9.305 ng/mL
Interval 8.755 to 11.733
|
11.706 ng/mL
Interval 10.927 to 14.416
|
283.73 ng/mL
Interval 268.35 to 383.63
|
341.92 ng/mL
Interval 329.13 to 462.35
|
12.581 ng/mL
Interval 11.697 to 17.502
|
13.687 ng/mL
Interval 12.713 to 17.3
|
PRIMARY outcome
Timeframe: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each periodThis Outcome is the time it takes a drug to reach Cmax
Outcome measures
| Measure |
Treatment A(Single Dose)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment A(Multiple Dose)
n=32 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Single Dose)
n=36 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Multiple Dose)
n=32 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose_Fimasartan)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose_Rosuvastatin)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose_Fimasartan)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose_Rosuvastatin)
n=34 Participants
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration
|
0.749 hr
Interval 0.5 to 2.0
|
0.635 hr
Interval 0.49 to 2.51
|
2.999 hr
Interval 1.0 to 5.03
|
4.505 hr
Interval 1.01 to 5.06
|
0.750 hr
Interval 0.5 to 1.5
|
0.751 hr
Interval 0.5 to 4.0
|
2.003 hr
Interval 1.0 to 5.0
|
1.506 hr
Interval 1.0 to 5.09
|
Adverse Events
Treatment A(Single Dose)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment A(Multiple Dose)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment B(Single Dose)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment B(Multiiple Dose)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment C(Single Dose)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment C(Multiple Dose)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A(Single Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment A(Multiple Dose)
n=33 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Single Dose)
n=35 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Multiiple Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Thoracic vertebral fracture
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Right clavicle fracture
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Right radius fracture
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
multiple closed rib fractures
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Right sided pneumothorax
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
Other adverse events
| Measure |
Treatment A(Single Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment A(Multiple Dose)
n=33 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Single Dose)
n=35 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment B(Multiiple Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Single Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
Treatment C(Multiple Dose)
n=34 participants at risk
Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)
There will be a washout of at least 7 days between the each period.
Treatment A: Fimasartan
Treatment B: Rosuvastatin
Treatment C: Fimasartan + Rosuvastatin
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
5.9%
2/34 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
3.0%
1/33 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
5.9%
2/34 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
6.1%
2/33 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
5.9%
2/34 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
5.9%
2/34 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
5.9%
2/34 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Nervous system disorders
Presyncope
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Nervous system disorders
somnolence
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
3.0%
1/33 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
3.0%
1/33 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
General disorders
Fatigue
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
5.9%
2/34 • Number of events 2 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
General disorders
Feeling hot
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
General disorders
Thirst
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
3.0%
1/33 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/35 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/33 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
3.0%
1/33 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/35 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
0.00%
0/34 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
2.9%
1/34 • Number of events 1 • Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Safety population included all population who receive at least 1 dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Obligation of disclosure restriction continue for 3 years from the date of termination or expiration of Agreement effected on November 16th, 2015.
- Publication restrictions are in place
Restriction type: OTHER