Comparison of Exposure and Activity of SAR341402 to NovoRapid in Healthy Japanese Male Subjects
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080225284
- Lead Sponsor
- Sanofi K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 36
Japanese male subjects, between 20 and 55 years of age, inclusive.
- Body weight between 50.0 and 90.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m^2, inclusive.
- Certified as healthy by a comprehensive clinical assessment.
- Normal vital signs.
- Standard 12-lead electrocardiogram parameters.
- Laboratory parameters within the normal ranges.
- Any history or presence of clinically relevant medical disorders.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- Symptomatic postural hypotension or asymptomatic postural hypotension.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse.
- Any subject who has participated in any other clinical study prior to study.
- Known hypersensitivity to insulin aspart or any of the excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>1. Assessment of PK parameter: Area under curve of plasma concentration<br>Area under curve to the last measurable concentration of SAR341402/insulin aspart (INS-AUClast)<br>[Time Frame: Day 1 of each treatment period]<br>pharmacokinetics<br>2. Assessment of PK parameter: Maximum plasma concentration<br>Maximum plama concentration of SAR341402/insulin aspart (INS-Cmax)<br>[Time Frame: Day 1 of each treatment period]<br>pharmacodynamics<br>3. Assessment of PD parameter: Area under curve of glucose infusion rate (GIR)<br>Area under the body weight standardized GIR versus time curve from time zero to 10 hours after dosing (GIR-AUC0-10)<br>[Time Frame: Day 1 of each treatment period]<br>pharmacodynamics<br>4. Assessment of PD parameter: Maximum GIR<br>Maximum smoothed body weight standardized GIR (GIRmax)<br>[Time Frame: Day 1 of each treatment period]
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>1. Assessment of PK parameter: Area under curve of pasma concentration<br>Area under curve extrapolated to infinity for SAR341402/insulin aspart (INS-AUC)<br>[Time Frame: Day 1 of each treatment period]<br>pharmacokinetics<br>2. Assessment of PK parameter: Half-life<br>Elimination half-life of SAR341402/insulin aspart (INS-t1/2z)<br>[Time Frame: Day 1 of each treatment period]<br>pharmacokinetics<br>3. Assessment of PK parameter: Time to reach Cmax<br>Time to reach Cmax of SAR341402/insulin aspart (INS-tmax)<br>[Time Frame: Day 1 of each treatment period]<br>pharmacodynamics<br>4. Assessment of PD parameter: Time to reach GIRmax<br>Time to reach GIRmax (GIR-tmax)<br>[Time Frame: Day 1 of each treatment period]<br>safety<br>5. Adverse events (AEs)<br>Number of subjects with Aes<br>[Time Frame: Up to 8 weeks]