OsteoporosisPhase 1NCT03234244
HDDO-1614 Intervention Trial
A Phase 1 study testing Bazedoxifene 20 mg, Cholecalciferol and Bazedoxifene 20mg and Cholecalciferol in people with Osteoporosis, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
Trial summary
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Bazedoxifene 20 mg, Cholecalciferol and Bazedoxifene 20mg and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Apr 2017to 14 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Osteoporosis
- Being tested
- Bazedoxifene 20 mg, Cholecalciferol, Bazedoxifene 20mg and Cholecalciferol
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene 20 mgDrug
To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
CholecalciferolDrug
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
Bazedoxifene 20mg and CholecalciferolDrug
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
| Study group | Role | What they receive |
|---|---|---|
| Bazedoxifene 20mg | Active comparator | Subjects will take bazedoxifene 1 Tablet. Receives: Drug: Bazedoxifene 20 mg |
| Cholecalciferol | Active comparator | Subjects will take Cholecalciferol 2 Tablets. Receives: Drug: Cholecalciferol |
| Bazedoxifene 20mg and Cholecalciferol | Experimental | Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once. Receives: Drug: Bazedoxifene 20mg and Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-Drug Interaction
To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
Measured: Day 1~Day 56
Secondary outcomes (4)
Pharmacokinetic Assessment
Bazedoxifene Maximum Plasma Concentration
Measured: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Pharmacokinetic Assessment
Bazedoxifene Area Under Curve
Measured: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Pharmacokinetic Assessment
Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol
Measured: 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
Area Under Curve after correction of basal concentration of Cholecalciferol
Measured: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start12 Apr 2017
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang-Heon Cho, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234244
- Sponsor's protocol ID
- HT-008-01
- Status last verified
- Apr 2017
- First submitted
- 26 Jul 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03234244
- Acronym / sponsor ID
- HT-008-01
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bazedoxifene 20mg | Active comparator | Drug: Bazedoxifene 20 mgSubjects will take bazedoxifene 1 Tablet. |
| Cholecalciferol | Active comparator | Drug: CholecalciferolSubjects will take Cholecalciferol 2 Tablets. |
| Bazedoxifene 20mg and Cholecalciferol | Experimental | Drug: Bazedoxifene 20mg and CholecalciferolSubjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bazedoxifene 20 mgTo estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time. | Drug | Bazedoxifene 20mg |
| CholecalciferolTo estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time. | Drug | Cholecalciferol |
| Bazedoxifene 20mg and CholecalciferolFor estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once. | Drug | Bazedoxifene 20mg and Cholecalciferol |
Primary outcome
Drug-Drug Interaction
Time frame: Day 1~Day 56
To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
4 secondary outcomes
Pharmacokinetic Assessment
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Heon Cho principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bazedoxifene 20 mg, Cholecalciferol and Bazedoxifene 20mg and Cholecalciferol in people with Osteoporosis, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-Drug Interaction (time frame: Day 1~Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017; AzTrials last refreshed its copy on 26 Oct 2026.