A Phase 1 interventional study of FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin in Diabetes Mellitus, sponsored by Korea University Anam Hospital. 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 2021-10-04.
Sponsored by Korea University Anam Hospital · Phase 1, Interventional, and Treatment
This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently.
On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Period 1: Individual components (ICs), period 2: FCDP
Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin
Period 1: FCDP, period 2: ICs
Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin
FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin
Cmax
peak plasma concentration
Time frame: 72 hours
AUC
area under plasma concentration versus time curve
Time frame: 72 hours
Tmax
time at Cmax
Time frame: 72 hours
half-life
elimination half-life
Time frame: 72 hours
CL
clearance
Time frame: 72 hours
Vd
volume distribution
Time frame: 72 hours
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Korea University Anam Hospital