Type 1 and 2 diabetes
Conditions
Interventions
BD32GX4 ->
3-7days ->
NV32GX6 ->
BD31GX8
BD32GX4 ->
BD31GX8 ->
NV32GX6
NV32GX6 ->
BD31GX8
NV32GX6 ->
BD32GX4
BD31GX8 ->
Sponsors
Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy and normal adult males, who voluntary register to enroll in this study at the medical institution, must meet the following criteria. A Healthy and normal adult male means one who satisfies the required conditions that his liver, kidney and electrocardiogram are normal and he is not infected by Hepatitis B, Hepatitis C, HIV and syphilis, etc, to become a subject for the phase 1 clinical study for drugs. *20 years old and over but under 40 years old. *Weight:55.0 kg and over but under 80.0kg *BMI:18.5kg/m2 and over but under 25.0kg/m2 *Body fat ratio:15% and over but under 20% *Systolic blood pressure: 90mmHg and over but under 140mmHg *Diastolic blood pressure:under 90mmHg *Pulse rate:40/min and over but under 100/min *HbA1c : under 5.2% (JDS value) *At 75g oral glucose tolerance test, fasting blood glucose level (venous plasma glucose level) is under 110mg/dl, and blood glucose level (venous plasma glucose level) is under 140mg/dl 120 minutes after glucose loading. *Subjects have every intention of completing all of the study procedures. *Subjects understand the contents of the consent form information and are willing to enroll in this study.
Exclusion criteria
Exclusion criteria: *Diabetic subjects, including treatment history *Subjects currently enrolled in another clinical study *Subjects who have risk in this study which is determined by a physician at the study site *Subjects who may have or may have had potentially a confusing factor in the interpretation of study results *Subjects who may be unsuitableness which is determined by a physician at the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The equivalency of pharmacokinetic parameters (Cmax, Tmax, AUC0-180) | — |
Countries
Japan
Outcome results
None listed