Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01982604 | Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers | PHASE1 | COMPLETED | 38 | — | — | Nov 1, 2013 | Aug 1, 2014 | Oct 2, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Sequence (Group) 1 | EXPERIMENTAL | Subjects randomized to Sequence 1 will receive TI in the following sequence: TI-Inhalation Powder A TI-Inhalation Powder B \*30 units (10 units + 20 units) |
| Sequence (Group) 2 | EXPERIMENTAL | Subjects randomized to Sequence 2 will receive TI in the following sequence: TI-Inhalation Powder B TI-Inhalation Powder A \*30 units (10 units + 20 units) |
| Name | Type | Description |
|---|---|---|
| TI-Inhalation Powder A | DRUG | Inhaled Insulin |
| TI-Inhalation Powder B | DRUG | Inhaled Insulin |
Inclusion Criteria: * Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * HNVs with a screening blood pressure less than 140/90 mm Hg * Subjects who have hypertension controlled with up to 1 medica...