Transfer of epinastine to infants through human breast milk

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223572

Enrollment

Registered

2017-06-25

Start date

2015-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

allergy

Interventions

investigational material(s) Generic name etc : epinastine INN of investigational material : epinastine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Seven nursing mothers volunteered to provide breast milk samples. The mothers were aged 31-38 years and had taken EPN hydrochloride (20 mg/d) once a day for more than 7 days before collection.

Exclusion criteria

Exclusion criteria: All the infants were healthy, of average size, and were without congenital disease or low birth weight. The health condition of each infant was checked by interviewing the mother after 6 months and 1 year

Design outcomes

Primary

Measure	Time frame
safety The safety of EPN in infants was further evaluated based on milk-to-plasma (M/P) ratios and relative infant doses (RIDs)	—

Secondary

Measure	Time frame
safety safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026