HDDO-1614 Intervention Trial

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03234244

Enrollment

Registered

2017-07-31

Start date

2017-04-12

Completion date

2017-08-14

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

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

Interventions

DRUGBazedoxifene 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.

DRUGCholecalciferol

To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.

DRUGBazedoxifene 20mg and Cholecalciferol

For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026