drugset / Trial / NCT02183311

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers

NCT02183311

Phase 1 Completed 56 enrolled Boehringer Ingelheim
RandomizedSingle-groupDouble-blindTreatment

Summary

Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg, and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)

Timeline

Start
2006-06
Primary completion
2006-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Linagliptin Small molecule 1 mg Oral
Subject Linagliptin Small molecule 2.5 mg Oral
Subject Linagliptin Small molecule 5 mg Oral
Subject Linagliptin Small molecule 10 mg Oral

Indications

No indication recorded.