| Outcome Measures: |
Primary: AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes, pmol·h/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) | Secondary: AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes, pmol·h/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour, pmol·h/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours, pmol·h/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours, pmol·h/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours, pmol·h/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|Cmax,IAsp, maximum observed serum insulin aspart concentration, pmol/L, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|tmax,IAsp, time to maximum observed serum insulin aspart concentration, Minutes, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|Onset of appearanceIAsp, time from trial product administration until the first time serum insulin aspart concentration greater than or equal to lower limit of quantification (LLOQ), Minutes, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp, Minutes, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp, Minutes, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|t½, terminal half-life for insulin aspart, Minutes, 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)|Number of treatment emergent adverse events, Count of Events, Until 7 days after IMP (investigational medicinal product) administration|Number of treatment emergent hypoglycaemic episodes, Count of Episodes, No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin)
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| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany|Phase 1 Clinical Trial Centre, Shatin, New Territories, Hong Kong, Postal Code: NA, Hong Kong|Phase 1 Clinical Trial Centre, Shatin, New Territories, Hong Kong
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