The infuence of bicarbonate on the behaviour of a drug in the stomach and small intestine and its implications for drug exposure.

Influence of bicarbonate on drug gastrointestinal behaviour and disposition

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001439-11-BE

Enrollment

Registered

2016-05-23

Start date

2016-06-28

Completion date

Unknown

Last updated

2020-06-02

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

Conditions

Healthy human volunteers (administration of an antipyretic, analgetic drug)

Interventions

Trade Name: DAFALGAN 500 mg tabletten Product Name: Dafalgan Pharmaceutical Form: Tablet INN or Proposed INN: Acetaminophen CAS Number: 103-90-2 Other descriptive name: PARACETAMOL Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - disease - acute/chronic GI condition - use of medication - pregnancy - frequent exposure to X-rays during the past year - HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
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). 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	—

Measure

Time frame

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). 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

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery and Disposition

KU Leuven

jens.vandenabeele@kuleuven.be+3216379105

Outcome results

None listed

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