NCT03321318

AK-R215 Pharmacokinetic Study Phase I

AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Alvogen Korea · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215

Detailed description

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AK-R215	Investigational product is prescribed to all ofrandomized subjects
DRUG	Bazedoxifene 20 mg	Investigational product is prescribed to all of randomized subjects
DRUG	Cholecalciferol 800IU	Investigational product is prescribed to all of randomized subjects

Timeline

• Start date: 2017-07-13
• Primary completion: 2017-09-18
• Completion: 2018-01-12
• First posted: 2017-10-25
• Last updated: 2017-10-25

Locations

1 site across 1 country: South Korea