NCT02806869

Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment: A Research Study to Evaluate the Performance of an Ibuprofen Oral Dosage Form in the Gastrointestinal Tract of Healthy Adult Volunteers

Completed NA Results posted Last updated 3 November 2017

What this trial tests

NA trial testing Single dose of ibuprofen (800 mg tablet) in Human Gastrointestinal Physiology Data in 48 participants. Completed in 1 July 2017.

Timeline

1 January 2015

Primary endpoint
1 November 2016

1 July 2017

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	48
Start date	1 January 2015
Primary completion	1 November 2016
Estimated completion	1 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Single dose of ibuprofen (800 mg tablet) — full drug profile →
• Pulmocare, two 8.0 oz (236.6 mL) cans

Conditions studied

• Human Gastrointestinal Physiology Data — all drugs for Human Gastrointestinal Physiology Data →

Sponsor

University of Michigan

Who can join

Adults 18 to 55, any sex, with Human Gastrointestinal Physiology Data. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen
  Time frame: from time 0 to 7 hours
  The pH of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation of duodenal fluid pH.

Sponsor's own description

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions.
   Koenigsknecht MJ, Baker JR, Wen B, Frances A, et al · · 2017 · cited 49× · PMID 28937221 · DOI 10.1021/acs.molpharmaceut.7b00425
2. Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach.
   Paixão P, Bermejo M, Hens B, Tsume Y, et al · · 2018 · cited 21× · PMID 29857136 · DOI 10.1016/j.ejpb.2018.05.033
3. Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State.
   Paixão P, Bermejo M, Hens B, Tsume Y, et al · · 2018 · cited 9× · PMID 30417648 · DOI 10.1021/acs.molpharmaceut.8b00736
4. Propagation Characteristics of Fasting Duodeno-Jejunal Contractions in Healthy Controls Measured by Clustered Closely-spaced Manometric Sensors.
   Baker JR, Dickens JR, Koenigsknecht M, Frances A, et al · · 2019 · cited 5× · PMID 30646481 · DOI 10.5056/jnm18112