Influence of green tea on pharmacokinetics of fexofenadine in healthy volunteers

Influence of green tea on pharmacokinetics of fexofenadine in healthy volunteers - Green tea - fexofenadine interaction study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032828

Enrollment

Registered

2018-06-01

Start date

2018-07-01

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

Healthy adults

Interventions

Volunteers receive 60 mg of fexofenadine (Dellegra combination tablet, Sanofi) with 200 mL of water after overnight fasting. Blood sample is collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours af

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility for participation in the trial is assessed by the following clinical laboratory data: total protein, 6.7-8.3 g/dL; total birilubin, 0.3-1.2 mg/dL; BUN: 8.0-22.0 mg/dL; creatinine, 0.61-1.04 mg/dL; AST, 10-40 U/L; ALT, 5-40 U/L; LDH, 115-245 U/L; WBC, 3900-9800 /uL; RBC, 427-570 x10000/uL; hemoglobin, 13.5-17.6 g/dL.

Exclusion criteria

Exclusion criteria: Smoker

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration-time curve (AUC) of fexofenadine	—

Secondary

Measure	Time frame
Urinary excretion of fexofenadine	—

Countries

Japan

Contacts

Public ContactShingen Misaka

Fukushima Medical University Department of bioregulation and pharmacological medicine

misaka@fmu.ac.jp024-547-1156

Outcome results

None listed

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