Trial · NCT01999400

Correlation of Mesalamine Pharmacokinetics With Local Availability

NCT01999400, Not applicable, Completed, University of Michigan; results first posted 2017-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Correlation of Mesalamine Pharmacokinetics With Local Availability. Trials, record NCT01999400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01999400

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Trial

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

Title: Correlation of Mesalamine Pharmacokinetics With Local Availability
NCT number: NCT01999400
Status: Completed
Phases: Not applicable
Enrollment: 30 participants, actual
Lead sponsor: University of Michigan
Conditions: Local Drug Concentration in Gastrointestinal Tract
Interventions: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Apriso 375 mg capsule x 3 with 240 mL water; single dose, Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
First posted: 2013-12-03
Last updated: 2017-05-15
Results first posted: 2017-05-15
Limitations and caveats: Evaluation of healthy volunteers that may not reflect patients with inflammatory bowel disease.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	The AUC of Mesalamine in Plasma	0 hours pre-dose and up to 96 hours post-dose	The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of mesalamine per liter of plasma (nM) multiplied by time in hours (nM\*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.
Primary	The AUC of Metabolite (N-acetyl-mesalamine) in Plasma	0 hours pre-dose and up to 96 hours post-dose	The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of N-acetyl-mesalamine per liter of plasma (nM) multiplied by time in hours (nM\*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.
Secondary	The AUC of Mesalamine in Distal Jejunum	0 hours pre-dose and up to 7 hours post-dose	The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM\*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.
Secondary	The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum	0 hours pre-dose and up to 7 hours post-dose	The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM\*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.

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	The AUC of Mesalamine in Plasma	0 hours pre-dose and up to 96 hours post-dose		nM*h	MEAN
PRIMARY	The AUC of Metabolite (N-acetyl-mesalamine) in Plasma	0 hours pre-dose and up to 96 hours post-dose		nM*h	MEAN
SECONDARY	The AUC of Mesalamine in Distal Jejunum	0 hours pre-dose and up to 7 hours post-dose	The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.	uM*h	MEAN
SECONDARY	The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum	0 hours pre-dose and up to 7 hours post-dose	The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.	uM*h	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
The AUC of Mesalamine in Plasma	Pentasa	40.8	Standard Deviation 29.5	nM*h
The AUC of Mesalamine in Plasma	Apriso	57.6	Standard Deviation 24.1	nM*h
The AUC of Mesalamine in Plasma	Lialda	36.8	Standard Deviation 16.0	nM*h
The AUC of Mesalamine in Plasma	Delzicol	7.9	Standard Deviation 3.7	nM*h
The AUC of Metabolite (N-acetyl-mesalamine) in Plasma	Pentasa	162	Standard Deviation 59.7	nM*h
The AUC of Metabolite (N-acetyl-mesalamine) in Plasma	Apriso	189	Standard Deviation 92.2	nM*h
The AUC of Metabolite (N-acetyl-mesalamine) in Plasma	Lialda	124	Standard Deviation 80.5	nM*h
The AUC of Metabolite (N-acetyl-mesalamine) in Plasma	Delzicol	20.4	Standard Deviation 7.7	nM*h
The AUC of Mesalamine in Distal Jejunum	Pentasa	8456	Standard Deviation 7444	uM*h
The AUC of Mesalamine in Distal Jejunum	Apriso	4923	Standard Deviation 8506	uM*h

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow126

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

Period	Milestone	Group	Participants
First Intervention (1 Day)	STARTED	Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda	6
First Intervention (1 Day)	STARTED	Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso	6
First Intervention (1 Day)	STARTED	Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda	5
First Intervention (1 Day)	STARTED	Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa	5
First Intervention (1 Day)	STARTED	Arm 5: Lialda Then Delzicol Then Pentasa Then Apriso	4
First Intervention (1 Day)	STARTED	Arm 6: Lialda Then Delzicol Then Apriso Then Pentasa	4
First Intervention (1 Day)	COMPLETED	Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda	4
First Intervention (1 Day)	COMPLETED	Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso	4
First Intervention (1 Day)	COMPLETED	Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda	3
First Intervention (1 Day)	COMPLETED	Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa	2

1 to 10 of 126Source ClinicalTrials.gov

See all 126 participant flow

Adverse events4

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	vasovagal syncope	Nervous system disorders	Pentasa	0	14
other	vasovagal syncope	Nervous system disorders	Apriso	0	13
other	vasovagal syncope	Nervous system disorders	Lialda	1	11
other	vasovagal syncope	Nervous system disorders	Delzicol	0	20

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pentasa
Total, all-cause mortality	Apriso
Total, all-cause mortality	Lialda
Total, all-cause mortality	Delzicol
Total, other adverse events	Pentasa	0	14
Total, other adverse events	Apriso	0	13
Total, other adverse events	Lialda	1	11
Total, other adverse events	Delzicol	0	20
Total, serious adverse events	Pentasa	0	14
Total, serious adverse events	Apriso	0	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18446510	BACKGROUND

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.

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