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Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects

NCT05406050 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-06-06

No results posted yet for this study

Summary

A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy Chinese subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

reference eldecalcitol soft capsule

0.75 μg, produced by Chugai Pharmaceutical Co., Ltd. Japan

DRUG

test eldecalcitol soft capsule

0.75 μg, produced by Wenzhou Haihe Pharmaceutical Co., Ltd. China

Sponsors & Collaborators

  • Wenzhou Haihe Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Yu Cao, Dr. · the study director of phase I clinical research center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2020-12-31
Completion
2021-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406050 on ClinicalTrials.gov