AK-R215 Pharmacokinetic Study Phase I

Alvogen

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Cholecalciferol 800IU; Drug: Bazedoxifene 20 mg; Drug: AK-R215

Study type: Interventional

Funder types: Industry

Identifiers

NCT03321318

AK-CTR-215-I-02

Details and patient eligibility

About

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

Full 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

Enrollment: 52 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

A group

Experimental group

Description:

AK-R215, test drug

Treatment:

Drug: AK-R215

Drug: Bazedoxifene 20 mg

Drug: Cholecalciferol 800IU

B group

Active Comparator group

Description:

reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU

Treatment:

Drug: AK-R215

Drug: Bazedoxifene 20 mg

Drug: Cholecalciferol 800IU