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| ID | Type | Description | Link |
|---|---|---|---|
| CA16652 | Other Identifier | Celerion |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ABC) | Other | 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. |
|
| Sequence 2 (ACB) | Other | 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. |
|
| Sequence 3 (BAC) | Other | 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. |
|
| Sequence 4 (BCA) | Other | 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. |
|
| Sequence 5 (CAB) | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve | This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method | 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 |
| Maximum Observed Concentration | 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. | 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 |
| Time to Reach Maximum Observed Plasma Concentration | This Outcome is the time it takes a drug to reach Cmax | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Sterling, M.D | Celelion, Inc. | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sequence 3 (BAC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve | This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method | Posted | Geometric Mean | 95% Confidence Interval | ng*hr/mL | 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 |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A(Single Dose) | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thoracic vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | It is resulted in discontinuation from the study. Approximately 3.4 days following dosing with rosuvastatin 20mg alone, the subject was cutting a tree branch when the branch fell on top of him and he was transported to the hospital via ambulance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Laura Sterling | Celerion | 1-402-476-2811 | laura.sterling@celerion.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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|
| Sequence 6 (CBA) | Other | 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. |
|
| Rosuvastatin | Drug |
|
| Fimasartan + Rosuvastatin | Drug |
|
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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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 |
| OG002 | Treatment B(Single Dose) | 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 |
| OG003 | Treatment B(Multiple Dose) | 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 |
| OG004 | Treatment C(Single Dose_Fimasartan) | 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 |
| OG005 | Treatment C(Single Dose_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 |
| OG006 | Treatment C(Multiple Dose_Fimasartan) | 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 |
| OG007 | Treatment C(Multiple Dose_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 |
|
|
| Primary | Maximum Observed Concentration | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 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 |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration | This Outcome is the time it takes a drug to reach Cmax | Posted | Median | Full Range | hr | 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 |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 2 |
| 34 |
| EG001 | Treatment A(Multiple Dose) | 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 | 0 | 33 | 0 | 33 | 6 | 33 |
| EG002 | Treatment B(Single Dose) | 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 | 0 | 35 | 0 | 35 | 6 | 35 |
| EG003 | Treatment B(Multiiple Dose) | 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 | 0 | 34 | 1 | 34 | 7 | 34 |
| EG004 | Treatment C(Single Dose) | 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 | 0 | 34 | 0 | 34 | 6 | 34 |
| EG005 | Treatment C(Multiple Dose) | 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 | 0 | 34 | 0 | 34 | 8 | 34 |
|
| Right clavicle fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Right radius fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| multiple closed rib fractures | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Right sided pneumothorax | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| somnolence | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
Obligation of disclosure restriction continue for 3 years from the date of termination or expiration of Agreement effected on November 16th, 2015.
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |