- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321318
AK-R215 Pharmacokinetic Study Phase I
October 22, 2017 updated by: Alvogen Korea
AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Busan, Korea, Republic of
- Dong-A University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A group
AK-R215, test drug
|
Investigational product is prescribed to all ofrandomized subjects
Investigational product is prescribed to all of randomized subjects
Investigational product is prescribed to all of randomized subjects
|
Active Comparator: B group
reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU
|
Investigational product is prescribed to all ofrandomized subjects
Investigational product is prescribed to all of randomized subjects
Investigational product is prescribed to all of randomized subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-t
Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
Cmax
Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax
Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
AUCinf,
Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
T1/2
Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2017
Primary Completion (Actual)
September 18, 2017
Study Completion (Anticipated)
January 12, 2018
Study Registration Dates
First Submitted
July 19, 2017
First Submitted That Met QC Criteria
October 22, 2017
First Posted (Actual)
October 25, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 22, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Micronutrients
- Hormone Antagonists
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Vitamin D
- Cholecalciferol
- Bazedoxifene
Other Study ID Numbers
- AK-CTR-215-I-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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