HDDO-1614 Intervention Trial

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234244
• Other study ID #: HT-008-01
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2017
• Last updated: December 8, 2017
• Start date: April 12, 2017
• Est. completion date: August 14, 2017

Study information

• Verified date: April 2017
• Source: Hyundai Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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, 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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• Cholecalciferol
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
• Bazedoxifene 20mg and Cholecalciferol
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.

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	Drug-Drug Interaction	To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.	Day 1~Day 56
Secondary	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	Pharmacokinetic Assessment	Bazedoxifene Area Under Curve	0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Secondary	Pharmacokinetic Assessment	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
Secondary	Pharmacokinetic Assessment	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