- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03234244
HDDO-1614 Intervention Trial
December 8, 2017 updated by: Hyundai Pharmaceutical Co., LTD.
A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
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
-
-
Incheon
-
Junggu, Incheon, Korea, Republic of, 22332
- Inha 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 to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body weight 50kg ≤ / BMI=18~29kg/㎡
- A person who is determined to be eligible for the test through a physical examination or an interview
- Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test
Exclusion Criteria:
- Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
- Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
Any person who shows any of the following results in the screening test
- AST or ALT > 2 times upper limit of normal range
- Total Bilirubin > 2.0mg/dL
- Glomerular filtration rate (eGFR) < 60mL / min/ 1.7㎡
- Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- Those who have a history of drug abuse or who have a positive urine drug test
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Bazedoxifene 20mg
Subjects will take bazedoxifene 1 Tablet.
|
To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
|
ACTIVE_COMPARATOR: Cholecalciferol
Subjects will take Cholecalciferol 2 Tablets.
|
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
|
EXPERIMENTAL: Bazedoxifene 20mg and Cholecalciferol
Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
|
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug-Drug Interaction
Time Frame: Day 1~Day 56
|
To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
|
Day 1~Day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Assessment
Time Frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
|
Bazedoxifene Maximum Plasma Concentration
|
0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
|
Pharmacokinetic Assessment
Time Frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
|
Bazedoxifene Area Under Curve
|
0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
|
Pharmacokinetic Assessment
Time Frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
|
Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol
|
Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
|
Pharmacokinetic Assessment
Time Frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
|
Area Under Curve after correction of basal concentration of Cholecalciferol
|
Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
|
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)
April 12, 2017
Primary Completion (ACTUAL)
August 14, 2017
Study Completion (ACTUAL)
August 14, 2017
Study Registration Dates
First Submitted
July 26, 2017
First Submitted That Met QC Criteria
July 26, 2017
First Posted (ACTUAL)
July 31, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 11, 2017
Last Update Submitted That Met QC Criteria
December 8, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- 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
- HT-008-01
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.
Clinical Trials on Osteoporosis
-
Radius Health, Inc.CompletedOsteoporosis | Osteoporosis Risk | Osteoporosis, Postmenopausal | Osteoporosis Fracture | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of Vertebrae | Osteoporosis VertebralUnited States
-
Radius Health, Inc.CompletedOsteoporosis | Age Related Osteoporosis | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of VertebraeUnited States, Poland, Italy
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
-
Hoffmann-La RocheGlaxoSmithKlineCompletedPost Menopausal OsteoporosisFrance
-
Novartis PharmaceuticalsCompletedPost-menopausal OsteoporosisColombia, Belgium, Sweden, Hong Kong, United States, Hungary, Switzerland, Australia, Germany, Italy, Canada, Poland, Argentina, Thailand, Norway, New Zealand, France, Finland
Clinical Trials on Bazedoxifene 20 mg
-
Wyeth is now a wholly owned subsidiary of PfizerTerminated
-
Alvogen KoreaUnknown
-
PfizerCompletedMenopause | OsteoporosisUnited States, Colombia, Australia, Hungary, Poland, Finland, Argentina, Chile, Denmark, Mexico, New Zealand, Norway
-
ObsEva SACompletedEndometriosisUnited States, Poland, Russian Federation, Ukraine
-
Hôpital FribourgeoisRecruitingBazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (BAZE)Pancreas CancerSwitzerland
-
Laval UniversityV Joseph; C Minville; C RheaumeRecruitingSleep Apnea | Oxidative Stress | Post MenopausalCanada
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
University of Southern CaliforniaNational Institute on Aging (NIA)RecruitingAtherosclerosis | Cognitive DeclineUnited States
-
Carol Fabian, MDBreast Cancer Research FoundationTerminatedFocus of Study is Healthy Women at Risk for Breast CancerUnited States