AK-R215 Pharmacokinetic Study Phase I

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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