HealthyPhase 1NCT05406050

Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects

A Phase 1 study testing reference eldecalcitol soft capsule and test eldecalcitol soft capsule in people with Healthy, run by The Affiliated Hospital of Qingdao University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: reference eldecalcitol soft capsule and test eldecalcitol soft capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteChina
Study dates: 20 Oct 2020to 15 Jul 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1)Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions;
2) Subjects are able to complete the study in compliance the study in compliance with the protocol;
3)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;
4)Healthy male and female subjects above 18 years of age ( inclusive);
5)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);

Who cannot join

1) allergic to two or more substances or to experimental drugs;
2) with a significant history of gastrointestinal inflammation/ulcer or other medical history affecting drug absorption or other diseases not appropriate to attend the trial;
3) serious disease, major surgery or a history of trauma 3 months before screening;
4) use of any medication including herbal medicine or healthcare products containing calcium, magnesium or vitamin D within 14 days before the first dose;
5) use of any investigational drug or product within 3 months prior to the first dose;
6) smoking more than five cigarettes a day in the last three months, or cannot quit smoking during the study period;

Show all 9Show fewer

7)alcoholics or drug abuser;
8)any abnormality with clinical significance of vital signs, physical examination, laboratory examination and electrocardiograph (ECG) examination;
9) 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.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003

Other trials in China

About this study

Official title: Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsule 0.75 ug in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Single-center, Single-dose, Open-label, Two-period Crossover Study

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

Read the detailed description

Eldecalcitol is a novel active vitamin D3,1,25(OH)2D3 derivative for the treatment of osteoporosis, which was first approved in Japanin 2011. With a hydroxy propoxy substituent at the 2βposition of 1,25(OH)2D3, eldecalcitol not only kept the high safety advantage but also showed much stronger effects on bone, such as improving bone metabolism, increasing bone mineral density(BMD) and preventing new vertebral fracture.Here in this study, we have compared the pharmacokinetic and bioequivalent profiles of two eldecalcitol soft capsule formulations at a single dose of 0.75 μg both under fasting and fed condition in healthy Chinese volunteers.

28 subjects participated in the fasting trial were randomly assigned to two groups to receive a single-dose of 0.75 μg reference eldecalcitol soft capsule (R, produced by Chugai Pharmaceutical Co., Ltd. Japan) or test capsule (T, produced by Wenzhou Haihe Pharmaceutical Co., Ltd. China) with about 240 ml warm water in the first treatment period and to receive another formulation in the second treatment period. There was a 21-day wash-out between the two treatment periods. For those participated in the fed trial, it was almost the same, except that 30 subjects had unified breakfast with high fat and high calories 30 minutes before dosing.Blood samples (8ml) for the determination of eldecalcitol were collected pre-dose and at 0.5,1,2,2.5,3,3.5,4,4.5,5,6,8,10,12,15,24,36,48,72,96,120,144, and 168 h post-dose in the fasting trial. And for those participated in the fed trial, blood samples (8ml) were collected pre-dose and at1,2,3,4,5,6,8,10,12, 14,16,24,28,36,48,72,96,120,144,168, and 192 h post-dose.

Conditions: Healthy
Being tested: reference eldecalcitol soft capsule, test eldecalcitol soft capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

reference eldecalcitol soft capsuleDrug
0.75 μg, produced by Chugai Pharmaceutical Co., Ltd. Japan
test eldecalcitol soft capsuleDrug
0.75 μg, produced by Wenzhou Haihe Pharmaceutical Co., Ltd. China

Study groups in NCT05406050
Study group	Role	What they receive
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. Receives: Drug: reference eldecalcitol soft capsule; Drug: 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. Receives: Drug: reference eldecalcitol soft capsule; Drug: test eldecalcitol soft capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: Day0-Day30
Area under the plasma concentration versus time curve (AUC0-t)
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
Measured: Day0-Day30
Area under the plasma concentration versus time curve (AUC0-∞)
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Measured: 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%
Measured: Day0-Day30

Secondary outcomes (1)

Safety
Collection of adverse events
Measured: Day0-Day30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202015 Jul 2021

First posted6 Jun 2022
Study start20 Oct 2020
Primary completion31 Dec 2020
Study completion15 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05406050
Sponsor's protocol ID: ZJHH-Eld
Status last verified: Jun 2022
First submitted: 1 Jun 2022
Last updated: 6 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsule 0.75 ug in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Single-center, Single-dose, Open-label, Two-period Crossover Study
ClinicalTrials.gov ID: NCT05406050
Acronym / sponsor ID: ZJHH-Eld
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
Collaborators: Wenzhou Haihe Pharmaceutical Co., Ltd.
Study start: 20 Oct 2020 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 15 Jul 2021 (actual)
First posted: 6 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TR	Experimental	Drug: reference eldecalcitol soft capsule, Drug: test eldecalcitol soft capsuleSubjects 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.
RT	Experimental	Drug: reference eldecalcitol soft capsule, Drug: test eldecalcitol soft capsuleSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

1)Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions;
2) Subjects are able to complete the study in compliance the study in compliance with the protocol;
3)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;
4)Healthy male and female subjects above 18 years of age ( inclusive);
5)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);

Key exclusion criteria (9 listed)

1) allergic to two or more substances or to experimental drugs;
2) with a significant history of gastrointestinal inflammation/ulcer or other medical history affecting drug absorption or other diseases not appropriate to attend the trial;
3) serious disease, major surgery or a history of trauma 3 months before screening;
4) use of any medication including herbal medicine or healthcare products containing calcium, magnesium or vitamin D within 14 days before the first dose;
5) use of any investigational drug or product within 3 months prior to the first dose;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
reference eldecalcitol soft capsule0.75 μg, produced by Chugai Pharmaceutical Co., Ltd. Japan	Drug	RT, TR
test eldecalcitol soft capsule0.75 μg, produced by Wenzhou Haihe Pharmaceutical Co., Ltd. China	Drug	RT, TR

Primary outcome

Peak Plasma Concentration (Cmax)
Time frame: Day0-Day30
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: Day0-Day30
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: Day0-Day30
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Bioequivalence
Time frame: Day0-Day30
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%

1 secondary outcome

Safety
Time frame: Day0-Day30

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yu Cao, Dr. principal investigator

the study director of phase I clinical research center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing reference eldecalcitol soft capsule and test eldecalcitol soft capsule in people with Healthy, run by The Affiliated Hospital of Qingdao University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: Day0-Day30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05406050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.