The infuence of bicarbonate on the behaviour of a drug in the stomach and small intestine and its implications for drug exposure.
Phase 1
- Conditions
- Healthy human volunteers(administration of an antipyretic, analgetic drug)Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2016-001439-11-BE
- Lead Sponsor
- KU Leuven - Drug Delivery and Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- healthy volunteers
- age: 18 - 35 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- disease
- acute/chronic GI condition
- use of medication
- pregnancy
- frequent exposure to X-rays during the past year
- HIV / HBV / HCV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the influence of bicarbonate on gastric motility by administering bicarbonate-containing beverages or plain water.;Secondary Objective: To evaluate the influence of possible changes to gastric motility, induced by bicarbonate administration, on gastrointestinal behaviour of an orally administered drug (Dafalgan).<br><br>To evaluate the influence of possible changes to gastric motility, induced by bicarbonate administration, on systemic exposure (pharmacokinetics) to an orally administered drug (Dafalgan).;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable