N/A
N=48
Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment
Human Gastrointestinal Physiology Data
Bottom Line
View on ClinicalTrials.gov: NCT02806869 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen — 5.12; 5.36 pH
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single dose of ibuprofen (800 mg tablet) (Drug); Pulmocare, two 8.0 oz (236.6 mL) cans (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen |
5.12; 5.36 | — |
| SECONDARY Maximum Duodenal Fluid Concentration of Ibuprofen in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen |
217; 155 | — |
| SECONDARY Average Area Under the Plasma Concentration-time Curve (AUC) in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen |
242; 229 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Adults age 18 to 55.
- Male or female voluntarily able to give informed consent.
Exclusion Criteria
- 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. Birth control is permitted.
- Received an investigational drug within 60 days prior to receiving the study drug.
- History of gastrointestinal surgery.
- Surgery within the past 3 months.
- History of allergy to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs).
- 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.
- Any clinically significant abnormal lab values during Screening.
Data sourced from ClinicalTrials.gov (NCT02806869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.