AK-R215 Pharmacokinetic Study Phase I

Phase 1

• Conditions: Healthy
• Interventions: Drug: AK-R215; Drug: Bazedoxifene 20 mg; Drug: Cholecalciferol 800IU

• Registration Number: NCT03321318
• Lead Sponsor: Alvogen Korea

Brief 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

Study Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-07-19
• Primary Completion: 2017-09-18
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-22
• Last Update Submitted: 2017-10-22
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25
• Study Completion: 2018-01-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B group	Bazedoxifene 20 mg	reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU
A group	AK-R215	AK-R215, test drug
A group	Cholecalciferol 800IU	AK-R215, test drug
A group	Bazedoxifene 20 mg	AK-R215, test drug
B group	AK-R215	reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU
B group	Cholecalciferol 800IU	reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU

Primary Outcome Measures

Name	Time	Method
AUC0-t	0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Cmax	0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h

Secondary Outcome Measures

Name	Time	Method
Tmax	0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
T1/2	0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
AUCinf,	0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h

Trial Locations

Locations (1)

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of