Status:
COMPLETED
Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults
Lead Sponsor:
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Conditions:
Postmenopausal Osteoporosis
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study. 64 qualified subjects will be randomly ...
Eligibility Criteria
Inclusion
- Those who volunteer to participate in the trial and sign the informed consent form.
- Healthy Chinese male or female adults, the number of single sex volunteers is no less than 1/3, aged 20 to 50 years old (including the boundary value).
- Males weighted ≥50kg, females weighted ≥45kg, body mass index (BMI) between 19-25 kg/m\^2 (including boundary value), BMI= weight (kg)/height\^2 (m\^2).
Exclusion
- The existence of clinically significant diseases of heart, liver, lung, kidney, digestive tract, endocrine, metabolic and hematological systems.
- history of parathyroid disease, or abnormal PTH with clinically significance judged by investigators.
- Physical examination, laboratory examination, electrocardiogram (ECG), chest radiograph, abdominal ultrasound san(digestive system, urinary system), vital signs, etc., indicate that the subject has clinically significant abnormalities judged by the investigator.
- Serum total calcium \> upper limit of normal according to the normal range of the center, or previous hypercalcemia.
- Hyperuricemia, or a previous history of gout, or abnormal blood uric acid with clinically significance judged by investigators at the time of screening.
- Those with active urolithiasis.
- Those who had received anti-osteoporosis agents (such as bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulator, parathyroid hormone and its analogues, strontium salts, active vitamin D and its analogues, vitamin K2, etc.) within 6 months before the first administration of the trial.
- Those who had received oral or intravenous administration of glucocorticoids 3 months before the first administration of the trial.
- Those who had taken any drug within 14 days before the first administration of the trial.
- Allergies, such as allergic to two or more kinds of drugs or food; or known allergic to this drug components.
- Alcoholism within 1 year before screening (drinking more than 3 times a day or more than 7 times a week, drinking 1 time =150mL red wine, or 360mL beer, or 50mL white wine), or a positive alcohol breath test.
- A history of drug abuse within 1 year before screening, or a positive urine test for drugs at screening.
- Those who were smoking more than 5 cigarettes a day within 3 months before screening.
- Those who had participated in any other clinical trial within 3 months before the first administration of the trial.
- Those who had blood donation or blood loss ≥400mL within 3 months before the first administration of the trial.
- Those who do not agree to avoid the use of tobacco, alcohol or caffeinated beverages within 24 hours before the administration and during the trial, or do not agree to avoid strenuous exercise, or do not agree to avoid other factors affecting the absorption, distribution, metabolism and excretion of the drug.
- Women who are pregnant or lactating, or who are positive for serum HCG, or who cannot/do not follow the instructions of investigators to take contraceptive measures approved by investigators during the study period.
- Those who intend to give birth within 1 year.
- Those with positive results of HBV surface antigen, or hepatitis C virus antibody positive, or Treponema pallidum antibody positive, or human immunodeficiency virus antibody positive.
- Those with positive results of novel coronavirus nucleic acid test.
- Those who are considered to be unsuitable for participation in this clinical study by investigators.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04747392
Start Date
August 19 2020
End Date
November 11 2020
Last Update
February 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China