Influence of obesity and gastric bypass on medication absorption: pharmacokinetic study

Influence of obesity and gastric bypass on medication absorption: pharmacokinetic study - INOGMA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001244-22-BE

Enrollment

135

Registered

2012-05-02

Start date

2012-07-16

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Obese volunteers and volunteers with a Roux-en-Y gastric bypass (RYGB)

Interventions

Trade Name: Xanthium 200 mg capsules Product Name: Theophylline Pharmaceutical Form: Modified-release capsule, hard Trade Name: Lipanthyl 67 Micronised Product Name: fenofibrate Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - obese volunteers who will undergo a RYGB and volunteers who underwent a RYGB > 6 months - minimum age: 18 years - for Microgynon: women between 18 and 45 years 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 135 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients with major postoperative gastrointestinal complications (e.g. anastomic leak or outlet obstruction) - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the influence of obesity and a gastric bypass on the absorption of drugs;Secondary Objective: - To compare two different formulations (immediate and controlled release) of theophyllin - To determine the effectiveness of oral contraception after RYGB;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 ContactIna Gesquiere

KU Leuven - Centre for Pharmacotherapy

ina.gesquiere@pharm.kuleuven.be3216323447

Outcome results

None listed

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