Trial Outcomes & Findings for Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment (NCT NCT02806869)

Last Updated: 2017-12-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

from time 0 to 7 hours

Results posted on

2017-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Arm #1 - Fasting State, 2 Study Visits 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Arm #2 - Fed State, 2 Study Visits 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
First Intervention (1 Day) STARTED	24	24
First Intervention (1 Day) COMPLETED	13	12
First Intervention (1 Day) NOT COMPLETED	11	12
Washout (7 Days) STARTED	7	7
Washout (7 Days) COMPLETED	7	7
Washout (7 Days) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	7	7
Second Intervention (1 Day) COMPLETED	7	5
Second Intervention (1 Day) NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm #1 - Fasting State, 2 Study Visits n=13 Participants 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Arm #2 - Fed State, 2 Study Visits n=12 Participants 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Total n=25 Participants Total of all reporting groups
Age, Continuous	29.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	31.6 years STANDARD_DEVIATION 8.8 • n=7 Participants	30.4 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	25.6 kg/m^2 STANDARD_DEVIATION 4.65 • n=5 Participants	26.2 kg/m^2 STANDARD_DEVIATION 4.61 • n=7 Participants	25.9 kg/m^2 STANDARD_DEVIATION 4.63 • n=5 Participants

PRIMARY outcome

Timeframe: from time 0 to 7 hours

Population: Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.

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.

Outcome measures

Outcome measures
Measure	Arm #1 - Fasting State, 2 Study Visits n=20 Participants 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Arm #2 - Fed State, 2 Study Visits n=17 Participants 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen	5.12 pH Standard Deviation 1.64	5.36 pH Standard Deviation 1.40

SECONDARY outcome

Timeframe: from time 0 to 7 hours

The concentration of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation maximum concentration measured in duodenal fluid.

Outcome measures

Outcome measures
Measure	Arm #1 - Fasting State, 2 Study Visits n=20 Participants 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Arm #2 - Fed State, 2 Study Visits n=17 Participants 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
Maximum Duodenal Fluid Concentration of Ibuprofen in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen	217 mg/L Standard Deviation 230	155 mg/L Standard Deviation 172

SECONDARY outcome

Timeframe: from time 0 to 24 hours

The plasma concentration of ibuprofen was measured at multiple timepoints over a 24 hour period. The reported value represents the mean and standard deviation of AUC over this time frame.

Outcome measures

Outcome measures
Measure	Arm #1 - Fasting State, 2 Study Visits n=20 Participants 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Arm #2 - Fed State, 2 Study Visits n=17 Participants 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
Average Area Under the Plasma Concentration-time Curve (AUC) in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen	242 h*mg/L Standard Deviation 88.9	229 h*mg/L Standard Deviation 76.9

Adverse Events

Arm #1 - Fasting State, 2 Study Visits

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm #2 - Fed State, 2 Study Visits

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm #1 - Fasting State, 2 Study Visits n=24 participants at risk 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red	Arm #2 - Fed State, 2 Study Visits n=24 participants at risk 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
Vascular disorders hypotension	0.00% 0/24	4.2% 1/24

Additional Information

Dr. Duxin Sun

University of Michigan

Phone: 734-615-8740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place