Pharmacokinetics of drugs used by pregnant women (paracetamol/macrolide antibiotics): in vivo pharmacokinetic study of pregnant versus non-pregnant women.

Pharmacokinetics of drugs used by pregnant women (paracetamol/macrolide antibiotics): in vivo pharmacokinetic study of pregnant versus non-pregnant women. - Pharmacokinetics of drugs used by pregnant women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000247-58-BE

Enrollment

150

Registered

2013-06-03

Start date

2013-09-30

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

1) Pregnant women who, due to medical indication, need to take one of the experimental drugs (paracetamol, azithromycin or erythromycin) in the second or third trimester of there pregnancy 2) The same women as in one but then 3 months post partum (healthy volunteers as control patients)

Interventions

Product Name: paracetamol Pharmaceutical Form: INN or Proposed INN: paracetamol CAS Number: 103-90-2 Current Sponsor code: PKZW-NZW201301 Other descriptive name: PARACETAMOL Product Name: erythromyc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - pregnant - clinical need to take one of the experimental drugs during the pregnancy - age between 18-40 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - use of medication - smoker

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is determine the pharmacokinetic parameters of paracetamol, erythromycin and azithromycin during the different stages of pregnancy. These values will be compared with the results of the same women in non pregnant state. ;Secondary Objective: The first aim is to determine whether or not dose adjustments are necessary during the pregnancy. The second aim is to get a better view on the impact of physiological changes on the distribution, elimination, metabolism and absorption of drugs during the pregnancy.;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: The aim of this study is determine the pharmacokinetic parameters of paracetamol, erythromycin and azithromycin during the different stages of pregnancy. These values will be compared with the results of the same women in non pregnant state. ;Secondary Objective: The first aim is to determine whether or not dose adjustments are necessary during the pregnancy. The second aim is to get a better view on the impact of physiological changes on the distribution, elimination, metabolism and absorption of drugs during the pregnancy.;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 ContactExperimentele Gynaecologie

KU Leuven

sigrid.conings@med.kuleuven.be3216341395

Outcome results

None listed

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