Levocetirizine/cetirizine levels in human milk – an observational, clinical study among breastfeeding women

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Human lactation study

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational human lactation study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CETIRIZINE

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Estimated number of subjects:
  25

Study design details

• Main study objective:
  Quantifying (levo)cetirizine excretion into human milk. Calculation of the relative infant dose (RID). Monitor the safety of (levo)cetirizine during breastfeeding.
• Outcomes:
  Variability of concentration of (levo)cetirizine in human milk samples. Maternal self-reported adverse events among breastfed infants. Maternal self-reported perceived changes in milk production
• Data analysis plan:
  Calculation of RID, pharmacokinetic modeling