Pharmacokinetic Properties of TAC-202 in the Fed and Fasted Conditions

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222717

Enrollment

Registered

2015-01-15

Start date

2015-01-15

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 adult male subjects

Interventions

investigational material(s) Generic name etc : TAC-202 INN of investigational material : bilastine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Subjects must be able to provide written informed consent by oneself. -Weight at least 50 kg and within the normal range according to accepted normal values of the Body Mass Index (BMI) of 18.5-25.0 kg/m2 at screening. -Subjects must be using no tobacco/nicotine during 90 days prior to first dose (Non-smoker).

Exclusion criteria

Exclusion criteria: -Subjects with complication (including symptoms or findings). -Subjects with a history of drug allergy. -Subjects with a history of adverse reaction which had received medical treatment to antihistamines.

Design outcomes

Primary

Measure	Time frame
Plasma pharmacokinetics parameters of TAC-202 Evaluate plasma pharmacokinetics parameters under fed with fasted conditions	—

Secondary

Measure	Time frame
Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, pulse, body temperature, clinical laboratory test, physical examination.	—

Outcome results

None listed

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