Clinical trial NCT04070794: Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type2 Diabetes
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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 administrations of investigational products of two consecutive periods.

A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)

Detailed description: \[Objectives\] Primary: To investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions

\[Admission and Confinement\] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in-house stay until 24 hours post-dose.

Fasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.

Eligibility criteria: Inclusion Criteria:

* Body mass index between 18.0 to 30.0 kg/m2.
* Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
* Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
* Female subjects abstain from either hormonal methods of contraception
* Male subjects who are willing or able to use effective contraceptive
* Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

Exclusion Criteria:

* History serious hypersensitivity reactions
* History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
* History or evidence of family diabetes
* History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
* History or evidence of shock or severe dehydrate or severe infection such as respiratory tract infection, urinary tract infection within 14 days prior to admission in each period
* History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period
* History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
* History of problems with swallowing tablet or capsule
* Difficulty fasting or consuming standardized meals
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* Any condition possibly affecting drug absorption
* Have renal creatinine clearance (Clcr) \< 45 mL/min based on serum creatinine results at the screening laboratory test
* 12-lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin
timeFrame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
measure: AUC0-tlast of gemigliptin, LC 15-0636 and metformin
timeFrame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
measure: AUC0-∞ of gemigliptin, LC 15-0636 and metformin
timeFrame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: International Bio Service Co., Ltd.
name: Uthai Suvanakoot
role: PRINCIPAL_INVESTIGATOR
References: