Trial · NCT01976572

Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects

NCT01976572, Phase 1, Completed, Tanabe Pharma Corporation; results first posted 2015-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects. Trials, record NCT01976572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976572

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
NCT number: NCT01976572
Status: Completed
Phases: Phase 1
Enrollment: 18 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Hyperphosphatemia, Chronic Kidney Disease
Interventions: colestilan, candesartan
First posted: 2013-11-06
Last updated: 2026-01-07
Results first posted: 2015-10-30

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	AUC0-t of Candesartan	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose	Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point
Primary	Cmax of Candesartan	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose	Maximum observed plasma concentration
Secondary	Tmax	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose	Time of maximum observed plasma concentration
Secondary	T1/2	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose	Apparent plasma terminal elimination half-life

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	AUC0-t of Candesartan	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose	PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.	ng*hr/mL	MEAN
PRIMARY	Cmax of Candesartan	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose	PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.	ng/mL	MEAN
SECONDARY	Tmax	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose		hr	MEDIAN
SECONDARY	T1/2	0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose		hr	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
AUC0-t of Candesartan	Candesartan Alone	1118	Standard Deviation 249	ng*hr/mL
AUC0-t of Candesartan	T-1hr	826	Standard Deviation 308	ng*hr/mL
AUC0-t of Candesartan	T0hr	494	Standard Deviation 127	ng*hr/mL
AUC0-t of Candesartan	T+3hr	759	Standard Deviation 211	ng*hr/mL
Cmax of Candesartan	Candesartan Alone	106.7	Standard Deviation 37.9	ng/mL
Cmax of Candesartan	T-1hr	94.7	Standard Deviation 58.3	ng/mL
Cmax of Candesartan	T0hr	42.8	Standard Deviation 7.0	ng/mL
Cmax of Candesartan	T+3hr	99.5	Standard Deviation 36.9	ng/mL
Tmax	Candesartan Alone	3.00	Full Range 2.00 to 4.00	hr
Tmax	T-1hr	3.00	Full Range 2.00 to 8.00	hr

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment A	6
Overall Study	STARTED	Treatment B	6
Overall Study	STARTED	Treatment C	6
Overall Study	COMPLETED	Treatment A	6
Overall Study	COMPLETED	Treatment B	6
Overall Study	COMPLETED	Treatment C	6
Overall Study	NOT COMPLETED	Treatment A	0
Overall Study	NOT COMPLETED	Treatment B	0
Overall Study	NOT COMPLETED	Treatment C	0

Source ClinicalTrials.gov

Adverse events105

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Candesartan Alone (Day 1 to 2)	0	18
other	Nausea	Gastrointestinal disorders	Colestilan Alone (Day 3 to 6)	2	18
other	Nausea	Gastrointestinal disorders	Candesartan Plus Colestilan (Day 7 to 24)	1	18
other	Constipation	Gastrointestinal disorders	Candesartan Alone (Day 1 to 2)	1	18
other	Constipation	Gastrointestinal disorders	Colestilan Alone (Day 3 to 6)	0	18
other	Constipation	Gastrointestinal disorders	Candesartan Plus Colestilan (Day 7 to 24)	1	18
other	Abdominal discomfort	Gastrointestinal disorders	Candesartan Alone (Day 1 to 2)	0	18
other	Abdominal discomfort	Gastrointestinal disorders	Colestilan Alone (Day 3 to 6)	1	18
other	Abdominal discomfort	Gastrointestinal disorders	Candesartan Plus Colestilan (Day 7 to 24)	0	18
other	Abdominal distension	Gastrointestinal disorders	Candesartan Alone (Day 1 to 2)	0	18

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Candesartan Alone (Day 1 to 2)
Total, all-cause mortality	Colestilan Alone (Day 3 to 6)
Total, all-cause mortality	Candesartan Plus Colestilan (Day 7 to 24)
Total, other adverse events	Candesartan Alone (Day 1 to 2)	5	18
Total, other adverse events	Colestilan Alone (Day 3 to 6)	10	18
Total, other adverse events	Candesartan Plus Colestilan (Day 7 to 24)	11	18
Total, serious adverse events	Candesartan Alone (Day 1 to 2)	0	18
Total, serious adverse events	Colestilan Alone (Day 3 to 6)	0	18
Total, serious adverse events	Candesartan Plus Colestilan (Day 7 to 24)	0	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01976572

GET https://conductscience.org/api/trials/v1/NCT01976572/events?page=2

API reference For AI assistants