NCT05406050

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2020

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 1, 2022

Last Update Submit

June 1, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Peak Plasma Concentration (Cmax)

    Evaluation of Peak Plasma Concentration (Cmax)

    Day0-Day30

  • Area under the plasma concentration versus time curve (AUC0-t)

    Evaluation of Area under the plasma concentration versus time curve (AUC0-t)

    Day0-Day30

  • Area under the plasma concentration versus time curve (AUC0-∞)

    Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)

    Day0-Day30

  • Bioequivalence

    Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%\~125.00%

    Day0-Day30

Secondary Outcomes (1)

  • Safety

    Day0-Day30

Study Arms (2)

TR

EXPERIMENTAL

Subjects first receive a single-dose of 0.75 μg test eldecalcitol soft capsule (T, produced by Wenzhou Haihe Pharmaceutical Co., Ltd. China) in the first treatment period and to receive the reference (R, produced by Chugai Pharmaceutical Co., Ltd. Japan) in the second treatment period.

Drug: reference eldecalcitol soft capsuleDrug: test eldecalcitol soft capsule

RT

EXPERIMENTAL

Subjects first receive a single-dose of 0.75 μg reference eldecalcitol soft capsule (R, produced by Chugai Pharmaceutical Co., Ltd. Japan) in the first treatment period and to receive test capsule (T, produced by Wenzhou Haihe Pharmaceutical Co., Ltd. China) in the second treatment period.

Drug: reference eldecalcitol soft capsuleDrug: test eldecalcitol soft capsule

Interventions

reference eldecalcitol soft capsuleDRUG

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

RTTR
test eldecalcitol soft capsuleDRUG

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

RTTR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • )Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions;
  • \) Subjects are able to complete the study in compliance the study in compliance with the protocol;
  • )Subjects (including male subjects) agree to adopt effective contraceptive methods and not plan to get pregnant or to donate sperm or ovum from 14 days before screening to 3 months after study completion;
  • )Healthy male and female subjects above 18 years of age ( inclusive);
  • )Ssubjects who are at least 50 kg, with a Body Mass Index (BMI)= Weight/Height2 (kg/m2) between 19.0-28.0 kg/m2 (both inclusive);

You may not qualify if:

  • \) allergic to two or more substances or to experimental drugs;
  • \) with a significant history of gastrointestinal inflammation/ulcer or other medical history affecting drug absorption or other diseases not appropriate to attend the trial;
  • \) serious disease, major surgery or a history of trauma 3 months before screening;
  • \) use of any medication including herbal medicine or healthcare products containing calcium, magnesium or vitamin D within 14 days before the first dose;
  • \) use of any investigational drug or product within 3 months prior to the first dose;
  • \) smoking more than five cigarettes a day in the last three months, or cannot quit smoking during the study period;
  • )alcoholics or drug abuser;
  • )any abnormality with clinical significance of vital signs, physical examination, laboratory examination and electrocardiograph (ECG) examination;
  • \) consumption of any caffeine-containing food or beverage, any beverage or food with abundant xanthine or any grapefruit or grapefruit-containing juices within 48 hours prior to receiving study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Study Officials

  • Yu Cao, Dr.

    the study director of phase I clinical research center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

October 20, 2020

Primary Completion

December 31, 2020

Study Completion

July 15, 2021

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

CN(1)