Local Drug Concentration in Gastrointestinal TractNCT01999400

Correlation of Mesalamine Pharmacokinetics With Local Availability

A study testing Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Apriso 375 mg capsule x 3 with 240 mL water; single dose and Lialda 1200 mg tablet x 1 with 240 mL water; single dose in people with Local Drug Concentration in Gastrointestinal Tract, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Local Drug Concentration in Gastrointestinal Tract
What is being tested?: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Apriso 375 mg capsule x 3 with 240 mL water; single dose and Lialda 1200 mg tablet x 1 with 240 mL water; single dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adults age 18 to 55.
Male or female voluntarily able to give informed consent.
Body mass index (BMI) 18.5 to 35.

Who cannot join

Adults unable to consent for themselves or mentally incapacitated.
Prisoners.
Significant clinical illness within 3 weeks prior to Screening.
Use of concomitant medications within 2 weeks prior to receiving study drug, including but not limited to prescription drugs, herbal and dietary supplements, over the counter medications, and vitamins. Oral contraception is permitted.
History of gastrointestinal surgery.
History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the ingredients of Asacol, Pentasa, Apriso, or Lialda.

Show all 13Show fewer

History of severe allergic diseases including drug allergies, with the exception of seasonal allergies.
Any other factor, condition, or disease, including, but not limited to, cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the patient or impact the validity of the study results.
History of drug addiction or alcohol abuse within the past 12 months.
Pregnant or lactating females.
Surgery within the past 3 months.
Received an investigational drug within 60 days prior to receiving the study drug.
Any clinically significant abnormal lab values during Screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

This study is designed to provide data to the FDA correlating pharmacokinetics with local availability of medications within the gastrointestinal tract. This study will support the establishment of scientifically based standards for evaluating drugs which act locally within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve the physiologically based models for drug absorption from the intestine. Information from this study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of mesalamine products.

Read the detailed description

This study evaluated the pharmacokinetics of mesalamine and its major metabolite of mesalamine known as N-acetyl-mesalamine in plasma. Mesalamine is available in different formulations that control the rate at which they are released in the gastrointestinal tract. Three formulations of mesalamine, Pentasa, Apriso, and Lialda, were studied in the crossover phase, while an oral solution formulation of mesalamine was studied in the single-arm phase. Each subject participated in a crossover phase study with one of the three formulations assigned at random using block randomization. Then the subject entered the single-arm phase study. After participation in one crossover phase study and one single-arm phase study, the subject could opt to participate in crossover phase studies using the other formulations also chosen at random until all three formulations were studied. The single-arm phase study was not repeated on returning subjects who participated in more than one crossover phase study.

Conditions: Local Drug Concentration in Gastrointestinal Tract
Being tested: 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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pentasa 500 mg capsule x 2 with 240 mL water; single doseDrug
Apriso 375 mg capsule x 3 with 240 mL water; single doseDrug
Lialda 1200 mg tablet x 1 with 240 mL water; single doseDrug
Delzicol 100 mg mesalamine x 1 with 245 mL water; single doseDrug

Study groups in NCT01999400
Study group	Role	What they receive
Arm 1: Pentasa then Delzicol then Apriso then Lialda	Experimental	1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. Receives: Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose; Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
Arm 2: Pentasa then Delzicol then Lialda then Apriso	Experimental	1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Apriso 375 mg capsule x 3 with 240 mL water, single dose. Receives: Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose; Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
Arm 3: Apriso then Delzicol then Pentasa then Lialda	Experimental	1. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. Receives: Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose; Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
Arm 4: Apriso then Delzicol then Lialda then Pentasa	Experimental	1. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. Receives: Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose; Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
Arm 5: Lialda then Delzicol then Pentasa then Apriso	Experimental	1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Apriso 375 mg capsule x 3 with 240 mL water, single dose. Receives: Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose; Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
Arm 6: Lialda then Delzicol then Apriso then Pentasa	Experimental	1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. Receives: Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose; Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose

What is being measured

The primary outcome is the main question the study is designed to answer.

The AUC of Mesalamine in Plasma
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.
Measured: 0 hours pre-dose and up to 96 hours post-dose
The AUC of Metabolite (N-acetyl-mesalamine) in Plasma
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.
Measured: 0 hours pre-dose and up to 96 hours post-dose

Secondary outcomes (2)

The AUC of Mesalamine in Distal Jejunum
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.
Measured: 0 hours pre-dose and up to 7 hours post-dose
The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum
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.
Measured: 0 hours pre-dose and up to 7 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Apr 2017

First posted3 Dec 2013 (estimated)
Study startApr 2012
Primary completionSep 2015
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Local Drug Concentration in Gastrointestinal TractStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01999400
Sponsor's protocol ID: FDA-SOL-1120920
Other IDs: HHSF223201300460A, HHSF223201000082C
Status last verified: May 2017
First submitted: 25 Nov 2013
Last updated: 15 May 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Lionberger RA. FDA critical path initiatives: opportunities for generic drug development. AAPS J. 2008;10(1):103-9. doi: 10.1208/s12248-008-9010-2. Epub 2008 Feb 20.
PubMed 18446510

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation of Mesalamine Pharmacokinetics With Local Availability
ClinicalTrials.gov ID: NCT01999400
Acronym / sponsor ID: FDA-SOL-1120920
Conditions: Local Drug Concentration in Gastrointestinal Tract
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Food and Drug Administration (FDA)
Study start: Apr 2012
Primary completion: Sep 2015 (actual)
Study completion: Apr 2017 (actual)
First posted: 3 Dec 2013 (estimated)
Results: Posted 15 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Arm 1: Pentasa then Delzicol then Apriso then Lialda	Experimental	Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose, Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
Arm 2: Pentasa then Delzicol then Lialda then Apriso	Experimental	Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose, Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
Arm 3: Apriso then Delzicol then Pentasa then Lialda	Experimental	Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose, Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose1. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
Arm 4: Apriso then Delzicol then Lialda then Pentasa	Experimental	Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose, Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose1. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
Arm 5: Lialda then Delzicol then Pentasa then Apriso	Experimental	Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose, Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
Arm 6: Lialda then Delzicol then Apriso then Pentasa	Experimental	Drug: Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Drug: Apriso 375 mg capsule x 3 with 240 mL water; single dose, Drug: Lialda 1200 mg tablet x 1 with 240 mL water; single dose, Drug: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose. 2. Washout period of 10 days. 3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose. 4. Washout period of 10 days. 5. Apriso 375 mg capsule x 3 with 240 mL water, single dose. 6. Washout period of 10 days. 7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Adults age 18 to 55.
Male or female voluntarily able to give informed consent.
Body mass index (BMI) 18.5 to 35.

Key exclusion criteria (13 listed)

Adults unable to consent for themselves or mentally incapacitated.
Prisoners.
Significant clinical illness within 3 weeks prior to Screening.
Use of concomitant medications within 2 weeks prior to receiving study drug, including but not limited to prescription drugs, herbal and dietary supplements, over the counter medications, and vitamins. Oral contraception is permitted.
History of gastrointestinal surgery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pentasa 500 mg capsule x 2 with 240 mL water; single dose	Drug	Arm 1: Pentasa then Delzicol then Apriso then Lialda, Arm 2: Pentasa then Delzicol then Lialda then Apriso, Arm 3: Apriso then Delzicol then Pentasa then Lialda, Arm 4: Apriso then Delzicol then Lialda then Pentasa, Arm 5: Lialda then Delzicol then Pentasa then Apriso, Arm 6: Lialda then Delzicol then Apriso then Pentasa
Apriso 375 mg capsule x 3 with 240 mL water; single dose	Drug	Arm 1: Pentasa then Delzicol then Apriso then Lialda, Arm 2: Pentasa then Delzicol then Lialda then Apriso, Arm 3: Apriso then Delzicol then Pentasa then Lialda, Arm 4: Apriso then Delzicol then Lialda then Pentasa, Arm 5: Lialda then Delzicol then Pentasa then Apriso, Arm 6: Lialda then Delzicol then Apriso then Pentasa
Lialda 1200 mg tablet x 1 with 240 mL water; single dose	Drug	Arm 1: Pentasa then Delzicol then Apriso then Lialda, Arm 2: Pentasa then Delzicol then Lialda then Apriso, Arm 3: Apriso then Delzicol then Pentasa then Lialda, Arm 4: Apriso then Delzicol then Lialda then Pentasa, Arm 5: Lialda then Delzicol then Pentasa then Apriso, Arm 6: Lialda then Delzicol then Apriso then Pentasa
Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose	Drug	Arm 1: Pentasa then Delzicol then Apriso then Lialda, Arm 2: Pentasa then Delzicol then Lialda then Apriso, Arm 3: Apriso then Delzicol then Pentasa then Lialda, Arm 4: Apriso then Delzicol then Lialda then Pentasa, Arm 5: Lialda then Delzicol then Pentasa then Apriso, Arm 6: Lialda then Delzicol then Apriso then Pentasa

Primary outcome

The AUC of Mesalamine in Plasma
Time frame: 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.
The AUC of Metabolite (N-acetyl-mesalamine) in Plasma
Time frame: 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.

2 secondary outcomes

The AUC of Mesalamine in Distal Jejunum
Time frame: 0 hours pre-dose and up to 7 hours post-dose
The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum
Time frame: 0 hours pre-dose and up to 7 hours post-dose

Results and safety

Results posted to the registry on 15 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda	6	4
Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso	6	4
Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda	5	3
Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa	5	2
Arm 5: Lialda Then Delzicol Then Pentasa Then Apriso	4	4
Arm 6: Lialda Then Delzicol Then Apriso Then Pentasa	4	3

Primary outcome: The AUC of Mesalamine in Plasma

Time frame: 0 hours pre-dose and up to 96 hours post-dose. Mean (Standard Deviation). Unit: nM*h

Measure	Pentasa n = 10	Apriso n = 7	Lialda n = 9	Delzicol n = 20
Value	40.8 (29.5)	57.6 (24.1)	36.8 (16.0)	7.9 (3.7)

Primary outcome: The AUC of Metabolite (N-acetyl-mesalamine) in Plasma

Time frame: 0 hours pre-dose and up to 96 hours post-dose. Mean (Standard Deviation). Unit: nM*h

Measure	Pentasa n = 10	Apriso n = 7	Lialda n = 9	Delzicol n = 20
Value	162 (59.7)	189 (92.2)	124 (80.5)	20.4 (7.7)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pentasa	0 of 14 (0%)	0 of 14 (0%)	Not reported
Apriso	0 of 13 (0%)	0 of 13 (0%)	Not reported
Lialda	0 of 11 (0%)	1 of 11 (9.1%)	Not reported
Delzicol	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): Evaluation of healthy volunteers that may not reflect patients with inflammatory bowel disease.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18446510Lionberger RA. FDA critical path initiatives: opportunities for generic drug development. AAPS J. 2008;10(1):103-9. doi: 10.1208/s12248-008-9010-2. Epub 2008 Feb 20.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duxin Sun, Ph.D. principal investigator

University of Michigan, College of Pharmacy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The AUC of Mesalamine in Plasma (time frame: 0 hours pre-dose and up to 96 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01999400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.