OsteoporosisPhase 1NCT03382314
HDDO-1614 Bio Equivalence Study
A Phase 1 study testing HDDO-1614 and Bazedoxifene / Cholecalciferol in people with Osteoporosis, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dose, crossover study Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- HDDO-1614 and Bazedoxifene / Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2017to 5 Jan 2018
- 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
- Men only
- 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, and 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 ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- Those who have a history of drug 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, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects
A randomized, open-label, single-dose, crossover study
Read the detailed description
This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).
- Conditions
- Osteoporosis
- Being tested
- HDDO-1614, Bazedoxifene / Cholecalciferol
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDDO-1614Combination product
- Combination drug (Bazedoxifene + Cholecalciferol)
- Incrementally modified drug
- Not market authorized product
Bazedoxifene / CholecalciferolDrug
Co- Administration of Bazedoxifene and Cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| HDDO-1614 | Experimental | Bazedoxifene + Cholecalciferol combination drug Receives: Combination Product: HDDO-1614 |
| Bazedoxifene + Cholecalciferol | Active comparator | Co-administration of Bazedoxifene and Cholecalciferol Receives: Drug: Bazedoxifene / Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bio-Equivalence between test drug and comparators
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
Measured: Day 1 ~ Day 27
Secondary outcomes (2)
Bazedoxifene 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
Cholecalciferol Pharmacokinetic Assessment
Maximum 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start16 Oct 2017
- Primary completion21 Dec 2017
- Study completion5 Jan 2018
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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382314
- Sponsor's protocol ID
- HT-008-02
- Status last verified
- Feb 2018
- First submitted
- 7 Dec 2017
- Last updated
- 26 Feb 2018
- 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 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT03382314
- Acronym / sponsor ID
- HT-008-02
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 22 Dec 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.
A randomized, open-label, single-dose, crossover study
Detailed description
This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDDO-1614 | Experimental | Combination Product: HDDO-1614Bazedoxifene + Cholecalciferol combination drug |
| Bazedoxifene + Cholecalciferol | Active comparator | Drug: Bazedoxifene / CholecalciferolCo-administration of Bazedoxifene and Cholecalciferol |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- 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, and 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 ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- Those who have a history of drug 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 |
|---|---|---|
| HDDO-1614* Combination drug (Bazedoxifene + Cholecalciferol) * Incrementally modified drug * Not market authorized product | Combination product | HDDO-1614 |
| Bazedoxifene / CholecalciferolCo- Administration of Bazedoxifene and Cholecalciferol | Drug | Bazedoxifene + Cholecalciferol |
Primary outcome
Bio-Equivalence between test drug and comparators
Time frame: Day 1 ~ Day 27
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
2 secondary outcomes
Bazedoxifene Pharmacokinetic Assessment
Time frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Cholecalciferol 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 26 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HDDO-1614 and Bazedoxifene / 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 26 Feb 2018. 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?
Bio-Equivalence between test drug and comparators (time frame: Day 1 ~ Day 27). 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 26 Feb 2018.