AK-R215 Pharmacokinetic Study Phase I

Alvogen Korea52 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AK-R215DRUG

Investigational product is prescribed to all ofrandomized subjects

Bazedoxifene 20 mgDRUG

Investigational product is prescribed to all of randomized subjects

Cholecalciferol 800IUDRUG

Investigational product is prescribed to all of randomized subjects

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BW is above 50kg and BMI is between 18.5 and 30.0 * Subject who agreed and signed on informed consent form prior to the study participation Exclusion Criteria: * Presence or history of clinically significant disease * Treatment history of any drug which might affect IP within 10days * History of other study drugs within 12weeks

Locations (1)

Dong-A University Hospital

Busan, South Korea