Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Collaborator: Wenzhou Haihe Pharmaceutical Co., Ltd.
• Treatments: Eldecalcitol; Vitamin D

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.