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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HGP0904+HGP0608+HGP1405 | Experimental | amlodipine + losartan + chlorthalidone |
|
| HGP0904 | Active Comparator | amlodipine |
|
| HGP0608 | Active Comparator | losartan |
|
| HGP1405 | Active Comparator | chlorthalidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGP0904 | Drug |
|
| |
| HGP0608 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | AUClast(Area under the curve to the last measurable concentration) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Cmax | Cmax(maxium concentration) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | AUCinf(Area under the curve to infinity) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Tmax | Tmax(Time to maximum concentration) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Paticipants With Adverse Events | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | Gyeonggi-do | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose) |
| FG001 | Sequence 2 | Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) |
| FG002 | Sequence 3 | Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose) |
| FG003 | Sequence 4 | Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C |
| BG001 | Sequence 2 | Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | AUClast | AUClast(Area under the curve to the last measurable concentration) | Posted | Geometric Mean | 90% Confidence Interval | Ratio(Comb/Alone) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
|
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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 | HGP0904 | amlodipine HGP0904 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Bundang Seoul National University Hospital | mekka@snu.ac.kr |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D019808 | Losartan |
| D002752 | Chlorthalidone |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
|
| HGP1405 | Drug |
|
|
| 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| T1/2 | T1/2(Terminal elimination half-life), | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| CL/F | CL/F(Apparent clearance) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Vz/F | Vz/F(Apparent volume of distribution) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| BG002 | Sequence 3 | Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A |
| BG003 | Sequence 4 | Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | EXP3174 | EXP3174(losartan active metabolite) ratio in single or combination |
|
|
| Primary | Cmax | Cmax(maxium concentration) | Not Posted | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Secondary | AUCinf | AUCinf(Area under the curve to infinity) | Not Posted | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Secondary | Tmax | Tmax(Time to maximum concentration) | Not Posted | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Secondary | T1/2 | T1/2(Terminal elimination half-life), | Not Posted | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Secondary | CL/F | CL/F(Apparent clearance) | Not Posted | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Secondary | Vz/F | Vz/F(Apparent volume of distribution) | Not Posted | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |
| Other Pre-specified | Number of Paticipants With Adverse Events | Not Posted | 3 months |
| 1 |
| 28 |
| 0 |
| 28 |
| EG001 | HGP0608 | losartan HGP0608 | 0 | 27 | 0 | 27 |
| EG002 | HGP1405 | chlorthalidone HGP1405 | 0 | 27 | 0 | 27 |
| EG003 | HGP0904+HGP0608+HGP1405 | amlodipine + losartan + chlorthalidone HGP0904 HGP0608 HGP1405 | 0 | 28 | 2 | 28 |
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| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |