Trial · NCT00983372

Drug-Drug Interaction Study Between Colchicine and Diltiazem ER

NCT00983372, Phase 1, Completed, Mutual Pharmaceutical Company, Inc.; results first posted 2009-09-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Drug-Drug Interaction Study Between Colchicine and Diltiazem ER. Trials, record NCT00983372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00983372

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Trial

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

Title: Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
NCT number: NCT00983372
Status: Completed
Phases: Phase 1
Enrollment: 24 participants, actual
Lead sponsor: Mutual Pharmaceutical Company, Inc.
Conditions: Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Interventions: Colchicine, Diltiazem ER, Colchicine
First posted: 2009-09-24
Last updated: 2009-10-15
Results first posted: 2009-09-24

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Maximum Plasma Concentration (Cmax)	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration	The maximum or peak concentration that colchicine reaches in the plasma.
Primary	Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration	The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.
Primary	Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration	The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Maximum Plasma Concentration (Cmax)	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration	pg/mL	MEAN
PRIMARY	Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration	pg-hr/mL	MEAN
PRIMARY	Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration	pg-hr/mL	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Maximum Plasma Concentration (Cmax)	Colchicine Alone	2,172.32	Standard Deviation 868.72	pg/mL
Maximum Plasma Concentration (Cmax)	Colchicine With Diltiazem (at Steady-state)	2,802.90	Standard Deviation 1,245.01	pg/mL
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	Colchicine Alone	10,035.57	Standard Deviation 4,562.57	pg-hr/mL
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	Colchicine With Diltiazem (at Steady-state)	17,729.64	Standard Deviation 8,642.59	pg-hr/mL
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	Colchicine Alone	12,025.69	Standard Deviation 5,418.95	pg-hr/mL
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	Colchicine With Diltiazem (at Steady-state)	22,485.97	Standard Deviation 10,994.16	pg-hr/mL

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Colchicine Alone	STARTED	Colchicine Alone / With Diltiazem (at Steady-state)	24
Colchicine Alone	COMPLETED	Colchicine Alone / With Diltiazem (at Steady-state)	24
Colchicine Alone	NOT COMPLETED	Colchicine Alone / With Diltiazem (at Steady-state)	0
14 Day Washout Period	STARTED	Colchicine Alone / With Diltiazem (at Steady-state)	24
14 Day Washout Period	COMPLETED	Colchicine Alone / With Diltiazem (at Steady-state)	23
14 Day Washout Period	NOT COMPLETED	Colchicine Alone / With Diltiazem (at Steady-state)	1
Diltiazem ER Alone	STARTED	Colchicine Alone / With Diltiazem (at Steady-state)	23
Diltiazem ER Alone	COMPLETED	Colchicine Alone / With Diltiazem (at Steady-state)	20
Diltiazem ER Alone	NOT COMPLETED	Colchicine Alone / With Diltiazem (at Steady-state)	3
Colchicine With Diltiazem ER	STARTED	Colchicine Alone / With Diltiazem (at Steady-state)	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events39

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	Events
other	dry eye	Eye disorders	Colchicine Alone	1	24	1
other	dry eye	Eye disorders	Diltiazem Alone	0	21	0
other	dry eye	Eye disorders	Colchicine With Steady-state Diltiazem	0	20	0
other	eye irritation	Eye disorders	Colchicine Alone	1	24	1
other	eye irritation	Eye disorders	Diltiazem Alone	0	21	0
other	eye irritation	Eye disorders	Colchicine With Steady-state Diltiazem	0	20	0
other	dyspepsia	Gastrointestinal disorders	Colchicine Alone	0	24	0
other	dyspepsia	Gastrointestinal disorders	Diltiazem Alone	1	21	1
other	dyspepsia	Gastrointestinal disorders	Colchicine With Steady-state Diltiazem	0	20	0
other	nausea	Gastrointestinal disorders	Colchicine Alone	1	24	1

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Colchicine Alone
Total, all-cause mortality	Diltiazem Alone
Total, all-cause mortality	Colchicine With Steady-state Diltiazem
Total, other adverse events	Colchicine Alone	6
Total, other adverse events	Diltiazem Alone	9
Total, other adverse events	Colchicine With Steady-state Diltiazem	4
Total, serious adverse events	Colchicine Alone	0	24
Total, serious adverse events	Diltiazem Alone	0	21
Total, serious adverse events	Colchicine With Steady-state Diltiazem	0	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21480191	DERIVED

Source PubMed

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/NCT00983372

GET https://conductscience.org/api/trials/v1/NCT00983372/events?page=2

API reference For AI assistants