HDDO-1614 Bio Equivalence Study

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Bazedoxifene / Cholecalciferol; Combination Product: HDDO-1614

• Registration Number: NCT03382314
• Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

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

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-18
• Primary Completion: 2017-12-21
• Study First Posted: 2017-12-22
• Study Completion: 2018-01-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bazedoxifene + Cholecalciferol	Bazedoxifene / Cholecalciferol	Co-administration of Bazedoxifene and Cholecalciferol
HDDO-1614	HDDO-1614	Bazedoxifene + Cholecalciferol combination drug

Primary Outcome Measures

Name	Time	Method
Bio-Equivalence between test drug and comparators	Day 1 ~ Day 27	To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614

Secondary Outcome Measures

Name	Time	Method
Bazedoxifene Pharmacokinetic Assessment	0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours	Bazedoxifene Maximum Plasma Concentration
Cholecalciferol Pharmacokinetic Assessment	Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour	Maximum Plasma Concentration after correction of basal concentration of Cholecalciferol

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Junggu, Incheon, Korea, Republic of