Status:
COMPLETED
HDDO-1614 Intervention Trial
Lead Sponsor:
Hyundai Pharmaceutical Co., LTD.
Conditions:
Osteoporosis
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
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, urine test, 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 ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- Those who have a history of drug abuse or who have a positive urine drug test
Key Trial Info
Start Date :
April 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03234244
Start Date
April 12 2017
End Date
August 14 2017
Last Update
December 11 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Inha University Hospital
Junggu, Incheon, South Korea, 22332