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NCT03321318 Clinical Trial

AK-R215 Pharmacokinetic Study Phase I

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03321318
Other study ID # AK-CTR-215-I-02
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received July 19, 2017
Last updated October 22, 2017
Start date July 13, 2017
Est. completion date January 12, 2018

Study information
Verified date October 2017
Source Alvogen Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 52
Est. completion date January 12, 2018
Est. primary completion date September 18, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• AK-R215
Investigational product is prescribed to all ofrandomized subjects
• Bazedoxifene 20 mg
Investigational product is prescribed to all of randomized subjects
• Cholecalciferol 800IU
Investigational product is prescribed to all of randomized subjects

Locations
Country Name City State
Korea, Republic of Dong-A University Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC0-t 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Primary Cmax 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Secondary Tmax 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Secondary AUCinf, 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Secondary T1/2 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
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