A Phase 1 interventional study of Janumet XR tablet 100/1000 mg and GLH1SM tablet 100/1000 mg in Healthy, sponsored by GL Pharm Tech Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-23.
Sponsored by GL Pharm Tech Corporation · Phase 1, Interventional, and Treatment
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition
2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet
GL Pharm Tech Corporation is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
Combination Product: GLH1SM tablet 100/1000 mg
Janumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
Combination Product: Janumet XR tablet 100/1000 mg
To administrate the Janumet XR tablet
Also known as: Sitagliptin and Metformin in Fixed Dose Combination
To administrate the GLH1SM tablet
Also known as: Sitagliptin and Metformin in Fixed Dose Combination
AUCt in ng·h/mL
Metformin
Time frame: 24 hours
Cmax in ng/mL
Metformin
Time frame: 24 hours
AUCinf in ng·h/mL
Metformin
Time frame: 24 hours
Tmax in hour
Metformin
Time frame: 24 hours
t1/2 in hour
Metformin
Time frame: 24 hours
CL/F in Liter/min/kg
Metformin
Time frame: 24 hours
Vd/F in Liter/kg
Metformin
Time frame: 24 hours
Adverse events
To 28 days after last IP administration
Time frame: 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Vital signs in blood pressure
Blood pressure(SBP, DBP)
Time frame: Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Vital signs in pulse
Pulse rate
Time frame: Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Vital signs in temperature
eardrum
Time frame: Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Physical examinations in weight
Weight in kilograms
Time frame: Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Physical examinations in height
Height in meters
Time frame: Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Clinical laboratories in blood sample
Normal blood chemistry, Type B hepatitis, Type C hepatitis, HIV, and Syphilis
Time frame: Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
12-lead ECG in clinical significance
QRS complex
Time frame: Screening(between 2 day and 28 day before IP administration), and one day between 3 day and 7 day after last blood sampling
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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GL Pharm Tech Corporation