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The primary objective is to assess the effects of colestilan on the pharmacokinetic profile of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours after the first daily dose of colestilan administered at doses of 5 g three times daily compared to administration of candesartan cilexetil alone, in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan alone | Placebo Comparator | Single dose of 16 mg candesartan was administered orally on Day 1. |
|
| T0hr | Active Comparator | Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d. T-0 of 3 dosing time-points means the single dose of candesartan was administered at the same time relative to the first daily dose of colestilan. |
|
| T-1hr | Active Comparator | Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d. T-1 of 3 dosing time-points means the single dose of candesartan was administered at 1 hour before relative to the first daily dose of colestilan. |
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| T+3hr | Active Comparator | Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d. T+3 of 3 dosing time-points means the single dose of candesartan was administered at 3 hour after relative to the first daily dose of colestilan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colestilan | Drug |
|
| |
| candesartan |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t of Candesartan | Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
| Cmax of Candesartan | Maximum observed plasma concentration | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of maximum observed plasma concentration | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
| T1/2 | Apparent plasma terminal elimination half-life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, Dr | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd. | Leeds | Springfield House Hyde Street | United Kingdom |
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Subjects were recruited at Covance from 14th October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
| FG001 |
| Treatment B |
On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0). |
| FG002 | Treatment C | On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | AUC0-t of Candesartan | Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point | PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data. | Posted | Mean | Standard Deviation | ng*hr/mL | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
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| Primary | Cmax of Candesartan | Maximum observed plasma concentration | PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data. | Posted | Mean | Standard Deviation | ng/mL | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Tmax | Time of maximum observed plasma concentration | Posted | Median | Full Range | hr | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
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| Secondary | T1/2 | Apparent plasma terminal elimination half-life | Posted | Mean | Standard Deviation | hr | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
|
|
24 days
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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 | Candesartan Alone (Day 1 to 2) | 0 | 18 | 5 | 18 | |||
| EG001 | Colestilan Alone (Day 3 to 6) | 0 | 18 | 10 | 18 | |||
| EG002 | Candesartan Plus Colestilan (Day 7 to 24) | 0 | 18 | 11 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 |
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| Abnormal faeces | Gastrointestinal disorders | MedDRA 16.0 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 |
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| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 |
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| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 |
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| Infrequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 16.0 |
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| Lip ulceration | Gastrointestinal disorders | MedDRA 16.0 |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 |
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| Headache | Nervous system disorders | MedDRA 16.0 |
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| Dizziness | Nervous system disorders | MedDRA 16.0 |
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| Lethargy | Nervous system disorders | MedDRA 16.0 |
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| Fatigue | General disorders | MedDRA 16.0 |
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| Chest pain | General disorders | MedDRA 16.0 |
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| Feeling hot | General disorders | MedDRA 16.0 |
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| Pyrexia | General disorders | MedDRA 16.0 |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
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| Eyelid skin dryness | Eye disorders | MedDRA 16.0 |
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| Ocular hyperaemia | Eye disorders | MedDRA 16.0 |
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| Alanine aminotransferase increased | Investigations | MedDRA 16.0 |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 |
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| Catheter site cellulitis | Infections and infestations | MedDRA 16.0 |
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| Middle insomnia | Psychiatric disorders | MedDRA 16.0 |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C106574 | cholebine |
| C081643 | candesartan |
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| Units | Counts |
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| Participants |
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