NCT03234244

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Hyundai Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Osteoporosis

Interventions

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

Timeline

• Start date: 2017-04-12
• Primary completion: 2017-08-14
• Completion: 2017-08-14
• First posted: 2017-07-31
• Last updated: 2017-12-11

Locations

1 site across 1 country: South Korea