PHARMACOKINETIC STUDY OF MAXACALCITOL

PHARMACOKINETIC STUDY OF MAXACALCITOL IN TAIWANESE AND JAPANESE MALE HEALTHY VOLUNTEERS

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223040

Enrollment

Registered

2015-12-10

Start date

2015-12-10

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

Secondary hyperparathyroidism in patients receiving maintenance dialysis

Interventions

investigational material(s) Generic name etc : Maxacalcitol INN of investigational material : maxacalcitol Therapeutic category code : 311 Vitamin A, D and preparations Dosage and Administration for I

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Main Inclusion Criteria 1. Male subject whose age is between 20 to 45 years with healthy condition at the time of consent acquisition. 2. Subject whose body mass index (BMI) is between 18.5 kg/m2 to 25.0 kg/m2.

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria 1. Subject who has current disease or history of hypercalcemia. 2. Subject whose laboratory test values is not within institutional normal range or specified range at the time of screening. 3. Subject who needs a concomitant drug during the study period. 4. Subject who is inappropriate to participate in this study judged by the investigator.

Design outcomes

Primary

Measure	Time frame
PK parameter PK analysis	—

Secondary

Measure	Time frame
Safety profile Adverse event, laboratory test	—

Outcome results

None listed

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