Status:
COMPLETED
Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Wenzhou Haihe Pharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy Chinese subjects under fasting conditions.
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,...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05406050
Start Date
October 20 2020
End Date
July 15 2021
Last Update
June 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003