Clincosm LogoSign in Get a demo

AK-R215 Pharmacokinetic Study Phase I

Sponsor
Alvogen Korea (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03321318
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: AK-R215
  • Drug: Bazedoxifene 20 mg
  • Drug: Cholecalciferol 800IU
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 13, 2017
Actual Primary Completion Date :
Sep 18, 2017
Anticipated Study Completion Date :
Jan 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: A group

AK-R215, test drug

Drug: AK-R215
Investigational product is prescribed to all ofrandomized subjects

Drug: Bazedoxifene 20 mg
Investigational product is prescribed to all of randomized subjects

Drug: Cholecalciferol 800IU
Investigational product is prescribed to all of randomized subjects
Active Comparator: B group

reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU

Drug: AK-R215
Investigational product is prescribed to all ofrandomized subjects

Drug: Bazedoxifene 20 mg
Investigational product is prescribed to all of randomized subjects

Drug: Cholecalciferol 800IU
Investigational product is prescribed to all of randomized subjects

Outcome Measures

Primary Outcome Measures

  1. AUC0-t [0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h]

  2. 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

  1. Tmax [0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h]

  2. AUCinf, [0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h]

  3. T1/2 [0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dong-A University Hospital Busan Korea, Republic of

Sponsors and Collaborators

  • Alvogen Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alvogen Korea
ClinicalTrials.gov Identifier:
NCT03321318
Other Study ID Numbers:
  • AK-CTR-215-I-02
First Posted:
Oct 25, 2017
Last Update Posted:
Oct 25, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Bazedoxifene

Study Results

No Results Posted as of Oct 25, 2017