Clinical trials: Gemigliptin
Type2 Diabetes
Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the…
- Trial name
- NCT04070794
- Testing
- Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting), Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy…
- Trial name
- NCT01662674
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
- Trial name
- NCT03864432
- Testing
- Gemigliptin 25mg, Gemigliptin 50mg, Gemigliptin 100mg
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy, Fasting
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under…
- Conditions
- Healthy, Fasting, Fed
- Trial name
- NCT07396844
- Testing
- Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy Male Volunteers
BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each…
- Trial name
- NCT03355014
- Testing
- Combination of gemigliptin/metformin HCl sustained release 50/1000mg, Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- LG Chem
T2DM
Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
- Trial name
- NCT04544319
- Testing
- Zemiglo 50mg and Forxiga 10mg, Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
- Trial name
- NCT02670070
- Testing
- gemigliptin 50mg, rosuvastatin 20mg
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2…
- Trial name
- NCT02670018
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Male Volunteers
Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.
- Trial name
- NCT01426906
- Testing
- Ketoconazole, rifampicin
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.
- Trial name
- NCT01825850
- Testing
- Gemigliptin, Irbesartan
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Volunteers
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg
A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in…
- Trial name
- NCT05105698
- Testing
- gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting), gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Chem
Diabetes Mellitus, Type 2, Dyslipidemias
BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.
To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.
- Trial name
- NCT03867942
- Testing
- Monolayer group, Bilayer group
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each…
- Trial name
- NCT01001013
- Testing
- LC15-0444, Pioglitazone
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Volunteers, Fasting Conditions
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
- Trial name
- NCT07399470
- Testing
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration…
- Trial name
- NCT01426399
- Testing
- LC15-0444, Metformin, LC15-0444+Metformin
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.
- Trial name
- NCT01595880
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Fed Conditions, Healthy Volunteer
A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
- Trial name
- NCT07333742
- Testing
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hepatic Impairment
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
- Trial name
- NCT02004587
- Testing
- Gemigliptin
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type 2 Diabetes
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
- Trial name
- NCT01747083
- Testing
- FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Diabetes Mellitus, Type 2
An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers
This is an open, randomized (randomization ratio: 1:1), multiple dose, three way, three period cross over study to assess the potential for drug drug interactions between gemigliptin (a DPP-IV inhibitor mainly metabolized by…
- Trial name
- NCT03310749
- Testing
- Gemigliptin, Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day, Metformin
- Where
- Mexico
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Stendhal Americas, S.A.