Overview

HDDO-1614 Intervention Trial

Status:
Completed
Trial end date:
2017-08-14
Target enrollment:
0
Participant gender:
All
Summary
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hyundai Pharmaceutical Co., LTD.
Treatments:
Bazedoxifene
Cholecalciferol
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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

1. AST or ALT > 2 times upper limit of normal range

2. Total Bilirubin > 2.0mg/dL

3. 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