HDDO-1614 Bio Equivalence Study

Hyundai Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: Bazedoxifene / Cholecalciferol

Combination Product: HDDO-1614

Study type

Interventional

Funder types

Industry

Identifiers

NCT03382314

HT-008-02

Details and patient eligibility

About

A randomized, open-label, single-dose, crossover study

Full 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, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).

Enrollment

38 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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