HDDO-1614 Intervention Trial

December 8, 2017 updated by: Hyundai Pharmaceutical Co., LTD.

A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects

Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Incheon
      • Junggu, Incheon, Korea, Republic of, 22332
        • Inha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bazedoxifene 20mg
Subjects will take bazedoxifene 1 Tablet.
Drug: Bazedoxifene 20 mg
To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
ACTIVE_COMPARATOR: Cholecalciferol
Subjects will take Cholecalciferol 2 Tablets.
Drug: Cholecalciferol
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
EXPERIMENTAL: Bazedoxifene 20mg and Cholecalciferol
Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Drug: Bazedoxifene 20mg and Cholecalciferol
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug-Drug Interaction
Time Frame: Day 1~Day 56
To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
Day 1~Day 56

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyundai Pharmaceutical Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2017

Primary Completion (ACTUAL)

August 14, 2017

Study Completion (ACTUAL)

August 14, 2017

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (ACTUAL)

July 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-008-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on Bazedoxifene 20 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe