A Phase 1 interventional study of HDDO-1614 and Bazedoxifene / Cholecalciferol in Osteoporosis, sponsored by Hyundai Pharmaceutical Co., LTD.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.
Sponsored by Hyundai Pharmaceutical Co., LTD. · Phase 1, Interventional, and Other
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Among 39 studies in Osteoporosis with a site in Korea, Republic of — 1 open to participants now, 1 under way, none of them phase 3. Osteoporosis · Korea, Republic of.
Among the 39 studies in Osteoporosis with a site in Korea, Republic of, this one is the 23rd largest by enrollment of the 26 interventional ones that give a count, is one of 6 that started in 2017, is one of 5 in phase 1, and was the 27th registered.
1,602 studies on the registry are indexed under Osteoporosis; 210 are open to participants now.
Browse Osteoporosis studies →1 of the 39 studies in Osteoporosis with a site in Korea, Republic of is open now. Recruiting first, the newest first:
Kyunghee University Dental Hospital · Sites in Korea, Republic of
Ages 20+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 133 Osteoporosis studies recruiting now, 77 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.
This study: 19 Years to 45 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 38 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Median enrollment 96 across the 26 interventional studies, 846 across the 13 observational. Of the 33 that completed or were terminated, 5 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 39 have an industry lead sponsor. The 10 most frequent:
Hyundai Pharmaceutical Co., LTD. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Hyundai Pharmaceutical Co., LTD. has 2 studies filed under Osteoporosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Osteoporosis with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07435259Kyunghee University Dental HospitalComparing Implant Retention Versus Removal for MRONJ at Implant Sites | 2027-03 |
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Among the 39 studies in Osteoporosis with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
A randomized, open-label, single-dose, crossover study
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any person who shows any of the following results in the screening test
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bazedoxifene + Cholecalciferol combination drug
Combination Product: HDDO-1614
Co-administration of Bazedoxifene and Cholecalciferol
Drug: Bazedoxifene / Cholecalciferol
* Combination drug (Bazedoxifene + Cholecalciferol) * Incrementally modified drug * Not market authorized product
Drug pages: Bazedoxifene · Cholecalciferol
Co- Administration of Bazedoxifene and Cholecalciferol
Bio-Equivalence between test drug and comparators
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
Time frame: Day 1 ~ Day 27
Bazedoxifene Pharmacokinetic Assessment
Bazedoxifene Maximum Plasma Concentration
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
Maximum Plasma Concentration after correction of basal concentration of Cholecalciferol
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
Ran from Oct 2017 to primary completion in Dec 2017, 2 months.
Of 30 phase 1 interventional studies under Osteoporosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 22. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Hyundai Pharmaceutical Co., LTD.