Status:
COMPLETED
HDDO-1614 Bio Equivalence Study
Lead Sponsor:
Hyundai Pharmaceutical Co., LTD.
Conditions:
Osteoporosis
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
A randomized, open-label, single-dose, crossover study
Detailed Description
This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, sing...
Eligibility Criteria
Inclusion
- Body weight 50kg ≤ / BMI=18\~29kg/㎡
- A person who is determined to be eligible for the test through a physical examination or an interview
- Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, and serology test
Exclusion
- Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
- Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
- Any person who shows any of the following results in the screening test
- AST or ALT \> 2 times upper limit of normal range
- Total Bilirubin \> 2.0mg/dL
- Glomerular filtration Rate(eGFR) \< 60mL/min/1.7㎡
- Those who show signs of hypotension (systolic blood pressure ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- Those who have a history of drug or who have a positive urine drug test
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2018
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03382314
Start Date
October 16 2017
End Date
January 5 2018
Last Update
February 26 2018
Active Locations (1)
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1
Inha University Hospital
Junggu, Incheon, South Korea, 22332