NCT03382314

HDDO-1614 Bio Equivalence Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hyundai Pharmaceutical Co., LTD. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Osteoporosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	HDDO-1614	* Combination drug (Bazedoxifene + Cholecalciferol) * Incrementally modified drug * Not market authorized product
DRUG	Bazedoxifene / Cholecalciferol	Co- Administration of Bazedoxifene and Cholecalciferol

Timeline

• Start date: 2017-10-16
• Primary completion: 2017-12-21
• Completion: 2018-01-05
• First posted: 2017-12-22
• Last updated: 2018-02-26

Locations

1 site across 1 country: South Korea