Status:
COMPLETED
An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers
Lead Sponsor:
Stendhal Americas, S.A.
Collaborating Sponsors:
Universidad Nacional Autonoma de Mexico
LG Chem
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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 inhibit...
Detailed Description
Consenting, eligible healthy adult subjects sequentially received either gemigliptin 50 mg q.d., metformin 1000 mg twice a day or gemigliptin 50 mg q.d. plus metformin 1000 mg twice a day during 3 con...
Eligibility Criteria
Inclusion
- Healthy male subjects at age between 20 and 45 at the screening test
- Subjects with a body weight of 55kg or more but less than 90kg and a Body Mass Index (BMI) of between 18.0 or more but less than 27.0
- BMI (kg/m2) = Weight (kg) / {Height (m)}2
- Subjects who show the blood glucose level within the range of 70-125 mg/dL at the fasting plasma glucose (FPG) test conducted at screening
- Subjects who fully understand this clinical trial after hearing a detailed explanation about it, make a decision to participate in it by his/her own free will, and sign an informed consent form to comply with the precautions
Exclusion
- Subjects who have a present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system, hematologic and oncologic disease, cardiovascular disease, or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc.) (including subjects carrying hepatitis virus in case of liver disease)
- Subjects with a past history of a gastrointestinal system disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or a gastrointestinal system surgery (however, subjects with a history of appendectomy or hernioplasty are not excluded)
- Subjects with a medical history of allergic reaction to drugs (aspirin, antibiotics, etc.) or clinically significant hypersensitivity reaction
- Subjects who show one of the following results at screening test:
- Exceeds 1.5 times the upper limit of the normal range of blood AST (SGOT) and ALT (SGPT)
- The creatinine clearance calculated by Cockcroft-Gault equation is below 80 mL/min.
- QTc \> 450 ms in ECG or clinically significant abnormal rhythm
- In the vital signs measured in sitting position after a rest for 3 minutes or longer, subjects who showed a systolic blood pressure of ≤ 100 mmHg or ≥ 150 mmHg, or a diastolic blood pressure of ≤ 60 mmHg or ≥ 95 mmHg)
- Subjects who have a past history of drug abuse or have shown a positive reaction to drugs that are used in abusive manner or cotinine at a urine drug screening
- Subjects who have taken any ethical drug or an herbal medication within 2 weeks before the date of first administration or have taken any over-the-counter (OTC) drug or vitamin preparation within 1 week (however, they can be included as subjects if considered appropriate at the investigator's discretion judgment)
- Subject who have already participated in other clinical trials within 2 months before the date of first drug administration
- Subject who have had whole blood donation within 2 months or component blood donation within 1 month before the date of first drug administration, or transfusion in 1 month before the date of first drug administration
- Subjects who have been drinking alcohol continuously (more than 21 units/week, 1 unit = 10 g of pure alcohol) or can't refrain from drinking alcohol during the clinical trial period
- Smokers (however, if the subject stopped smoking more than 3 months before the date of the first drug administration, he/she can be selected as a subject)
- 12\) Subjects who have had grapefruit/ any food containing caffeine within 3 days before the date of the first drug administration
Key Trial Info
Start Date :
January 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03310749
Start Date
January 15 2016
End Date
May 3 2016
Last Update
October 16 2017
Active Locations (1)
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1
Unidad de Farmacología Clínica de la Facultad de Medicina de la Universidad Nacional Autónoma de México
Nezahualcóyotl, State of Mexico, Mexico, 57740