Bioavailability of a ColoPulse tablet

BIOavailability of a COloPulse tablet in healthy volunteers and Crohn's patients; influence of gastro-intestinal pH, food and time of food intake

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18301880

Enrollment

Registered

2014-12-18

Start date

2011-01-25

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Release of a ColoPulse tablet in healthy volunteers and patients with Crohn's disease (in remission) Not Applicable

Interventions

Period 1: an oral dose of 50 mg 15N2-ureum immediate release tablet in combination with an oral dose of 50 mg 13C-ureum modified-release tablet at Day 1 in a fasted condition. Non-standardized breakfa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy adults (18-65 years) able to sign informed consent 2. No medication use during the last 3 months that can influence the gastrointestinal flora (e.g., antibiotics) 3. No medication use during the last 4 weeks of drugs that may affect the gastrointestinal transit time (e.g., laxatives, antacids) 4. No use of NSAIDs during the last 4 weeks Patients 1. Adults (18-65 years) able to sign informed consent with Crohn's disease (in remission Harvey Bradshaw index =3) (18-65) 2. No medication use during the last 3 months of drugs that may affect the gastrointestinal flora (e.g., antibiotics) 3. No medication use of drugs that may affect the gastrointestinal pH (e.g., antacids)

Exclusion criteria

Exclusion criteria: Healthy volunteers 1. With known gastro-intestinal disorders such as ulcerative colitis, Crohn's disease, spastic colon, colon cancer, ileus, ostomy, gastric and/or intestinal infection 2. Gastrointestinal operation (except appendix operation) 3. Presence Helicobacter pylori Patients 1. Crohn's disease is in the active stage (Harvey Bradshaw = 4) 2. Presence Helicobacter p ylori

Design outcomes

Primary

Measure	Time frame
1. Local bioavailability in healthy volunteers and patients with Crohn's disease. 2. Time between intake and response in healthy volunteers and patients with Crohn's disease. This is the cumPDR 5%: (lagtime) at the time when release exceeds 5% of the maximum cumPDR (13 C-urea). 3. Pulse time in healthy volunteers and patients with Crohn's disease. This is the difference between times at which the maximum PDR is reached and the lagtime. 4. Description of the gastro-intestinal pH profile of healthy volunteers.	—

Measure

Time frame

1. Local bioavailability in healthy volunteers and patients with Crohn's disease. 2. Time between intake and response in healthy volunteers and patients with Crohn's disease. This is the cumPDR 5%: (lagtime) at the time when release exceeds 5% of the maximum cumPDR (13 C-urea). 3. Pulse time in healthy volunteers and patients with Crohn's disease. This is the difference between times at which the maximum PDR is reached and the lagtime. 4. Description of the gastro-intestinal pH profile of healthy volunteers.

—

Secondary

Measure	Time frame
Investigate influence of food and time of food intake on functioning of a ColoPulse dosage form	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026