HDDO-1614 Bio Equivalence Study

• Status: Completed
• Trial end date: 2018-01-05
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized, open-label, single-dose, 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, and 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 ≤ 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