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A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
Details
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | 1999-01 |
Conditions
- Healthy
Interventions
- BIIX 1 XX inhalation solution
- Placebo
Primary outcomes
- Number of patients with adverse events — up to 22 days
- Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate) — up to 8 days after drug administration
- Number of patients with clinically relevant changes in electrocardiogram (ECG) — up to 8 days after drug administration
- Number of patients with clinically relevant changes in impedance cardiography — pre-dose, 10 and 30 minutes after administration
- Number of patients with clinically relevant changes in cutaneous microcirculation — pre-dose, 10 and 30 minutes after administration
- Number of patients with clinically relevant changes in safety laboratory parameters — up to 8 days after drug administration