A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02704702
Collaborator
(none)
36
6
3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Study Start Date
:
Mar 1, 2016
Actual Primary Completion Date
:
Jun 1, 2016
Actual Study Completion Date
:
Jun 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
|
| Other: 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. |
Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
|
| Other: 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. |
Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
|
| Other: 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. |
Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
|
| Other: 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. |
Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
|
| Other: 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. |
Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
|
Outcome Measures
Primary Outcome Measures
- Area Under the Concentration-time Curve [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]
This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
- Maximum Observed Concentration [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]
This 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.
- Time to Reach Maximum Observed Plasma Concentration [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]
This Outcome is the time it takes a drug to reach Cmax
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Caucasian male 19-55 years of age.
-
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
-
Medically healthy with no clinically significant medical history.
-
Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
Exclusion Criteria:
-
History or presence of clinically significant medical or psychiatric condition or disease.
-
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
-
Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
-
Plasma donation within 7 days prior to the first dose of study drug.
-
Participation in another clinical trial within 28 days prior to the first dose of study drug(s).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boryung Pharmaceutical Co., Ltd
Investigators
- Principal Investigator: Laura Sterling, M.D, Celelion, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02704702
Other Study ID Numbers:
- BR-FRC-CT-102
- CA16652
First Posted:
Mar 10, 2016
Last Update Posted:
Nov 2, 2018
Last Verified:
Feb 1, 2018
Keywords provided by Boryung Pharmaceutical Co., Ltd
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sequence 1 (ABC) | Sequence 2 (ACB) | Sequence 3 (BAC) | Sequence 4 (BCA) | Sequence 5 (CAB) | Sequence 6 (CBA) |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 |
| Period Title: Overall Study | ||||||
| STARTED | 6 | 6 | 6 | 6 | 6 | 6 |
| COMPLETED | 5 | 6 | 6 | 5 | 4 | 4 |
| NOT COMPLETED | 1 | 0 | 0 | 1 | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Sequence 2 (ACB) | Sequence 3 (BAC) | Sequence 1 (ABC) | Sequence 4 (BCA) | Sequence 5 (CAB) | Sequence 6 (CBA) | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 of all reporting groups |
| Overall Participants | 6 | 6 | 6 | 6 | 6 | 6 | 36 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
36
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
36
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
0
0%
|
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
2
5.6%
|
| Not Hispanic or Latino |
6
100%
|
5
83.3%
|
6
100%
|
5
83.3%
|
6
100%
|
6
100%
|
34
94.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
36
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Area Under the Concentration-time Curve |
|---|---|
| Description | This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiple Dose) | Treatment C(Single Dose_Fimasartan) | Treatment C(Single Dose_Rosuvastatin) | Treatment C(Multiple Dose_Fimasartan) | Treatment C(Multiple Dose_Rosuvastatin) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 34 | 32 | 35 | 32 | 34 | 34 | 34 | 34 |
| Geometric Mean (95% Confidence Interval) [ng*hr/mL] |
690.43
|
820.86
|
86.442
|
114.55
|
702.20
|
85.078
|
880.19
|
98.957
|
| Title | Maximum Observed Concentration |
|---|---|
| Description | This 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiple Dose) | Treatment C(Single Dose_Fimasartan) | Treatment C(Multiple Dose_Fimasartan) | Treatment C(Single Dose_Rosuvastatin) | Treatment C(Multiple Dose_Rosuvastatin) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 34 | 32 | 35 | 32 | 34 | 34 | 34 | 34 |
| Geometric Mean (95% Confidence Interval) [ng/mL] |
289.12
|
362.14
|
9.305
|
11.706
|
283.73
|
341.92
|
12.581
|
13.687
|
| Title | Time to Reach Maximum Observed Plasma Concentration |
|---|---|
| Description | This Outcome is the time it takes a drug to reach Cmax |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiple Dose) | Treatment C(Single Dose_Fimasartan) | Treatment C(Multiple Dose_Fimasartan) | Treatment C(Single Dose_Rosuvastatin) | Treatment C(Multiple Dose_Rosuvastatin) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 34 | 32 | 36 | 32 | 34 | 34 | 34 | 34 |
| Median (Full Range) [hr] |
0.749
|
0.635
|
2.999
|
4.505
|
0.750
|
0.751
|
2.003
|
1.506
|
Adverse Events
| Time Frame | Participants assessed 13 days for each intervention, a total of approximately 4 weeks | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all population who receive at least 1 dose of study drug | |||||||||||
| Arm/Group Title | Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiiple Dose) | Treatment C(Single Dose) | Treatment C(Multiple Dose) | ||||||
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | ||||||
All Cause Mortality |
||||||||||||
| Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiiple Dose) | Treatment C(Single Dose) | Treatment C(Multiple Dose) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/33 (0%) | 0/35 (0%) | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiiple Dose) | Treatment C(Single Dose) | Treatment C(Multiple Dose) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/33 (0%) | 0/35 (0%) | 1/34 (2.9%) | 0/34 (0%) | 0/34 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Thoracic vertebral fracture | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Right clavicle fracture | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Right radius fracture | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| multiple closed rib fractures | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Right sided pneumothorax | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Treatment A(Single Dose) | Treatment A(Multiple Dose) | Treatment B(Single Dose) | Treatment B(Multiiple Dose) | Treatment C(Single Dose) | Treatment C(Multiple Dose) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/34 (5.9%) | 6/33 (18.2%) | 6/35 (17.1%) | 7/34 (20.6%) | 6/34 (17.6%) | 8/34 (23.5%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Diarrhoea | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 | 1/35 (2.9%) | 1 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 |
| General disorders | ||||||||||||
| Fatigue | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 2/34 (5.9%) | 2 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 |
| Feeling hot | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 |
| Thirst | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/35 (0%) | 0 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 |
| Vessel puncture site pain | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/35 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/35 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Back pain | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/35 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Muscle spasms | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/35 (0%) | 0 | 0/34 (0%) | 0 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Musculoskeletal chest pain | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/35 (2.9%) | 1 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Musculoskeletal stiffness | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| Neck pain | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/35 (0%) | 0 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 |
| Pain in extremity | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 0/34 (0%) | 0 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 |
| Nervous system disorders | ||||||||||||
| Dizziness | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/35 (2.9%) | 1 | 0/34 (0%) | 0 | 2/34 (5.9%) | 2 | 1/34 (2.9%) | 1 |
| Dizziness postural | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/35 (0%) | 0 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 | 2/34 (5.9%) | 2 |
| Headache | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 | 0/35 (0%) | 0 | 2/34 (5.9%) | 2 | 2/34 (5.9%) | 2 | 2/34 (5.9%) | 2 |
| Presyncope | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 0/34 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 |
| Sensory disturbance | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/35 (0%) | 0 | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
| somnolence | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/35 (2.9%) | 1 | 0/34 (0%) | 0 | 0/34 (0%) | 0 | 0/34 (0%) | 0 |
Limitations/Caveats
Several sampling time deviations occurred during the clinical conduct of this study. Actual sampling times relative to dosing time were used for caculation of PK parameters.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Obligation of disclosure restriction continue for 3 years from the date of termination or expiration of Agreement effected on November 16th, 2015.
Results Point of Contact
| Name/Title | Dr.Laura Sterling |
|---|---|
| Organization | Celerion |
| Phone | 1-402-476-2811 |
| laura.sterling@celerion.com |
Responsible Party:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02704702
Other Study ID Numbers:
- BR-FRC-CT-102
- CA16652
First Posted:
Mar 10, 2016
Last Update Posted:
Nov 2, 2018
Last Verified:
Feb 1, 2018