HDDO-1614 Bio Equivalence Study

Osteoporosis Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382314
• Other study ID #: HT-008-02
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2017
• Last updated: February 23, 2018
• Start date: October 16, 2017
• Est. completion date: January 5, 2018

Study information

• Verified date: February 2018
• Source: Hyundai Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 5, 2018
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Combination Product:
• HDDO-1614
Combination drug (Bazedoxifene + Cholecalciferol) Incrementally modified drug Not market authorized product

Drug:
• Bazedoxifene / Cholecalciferol
Co- Administration of Bazedoxifene and Cholecalciferol

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Junggu	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Hyundai Pharmaceutical Co., LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bio-Equivalence between test drug and comparators	To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614	Day 1 ~ Day 27
Secondary	Bazedoxifene Pharmacokinetic Assessment	Bazedoxifene Maximum Plasma Concentration	0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Secondary	Cholecalciferol Pharmacokinetic Assessment	Maximum 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