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Clinical trial

Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BIRT 1696 BS as a Solution (10, 100, 400, 1000, 2000, 3000 mg) in 15 ml PEG 400 to Healthy Human Subjects. A Three Part Study: Part 1 Placebo-controlled, Randomised, Dose Escalating Double Blinded Within Each Dose Level; Part 2 Open Label Grapefruit Juice Effect in 100 mg Dose Level Group; Part 3 Open Label Food Effect in 400 mg Dose Level Group

NCT02254096 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.

NCT NCT02254096
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Registry record

As filed in ClinicalTrials.gov.

Title
Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BIRT 1696 BS as a Solution (10, 100, 400, 1000, 2000, 3000 mg) in 15 ml PEG 400 to Healthy Human Subjects. A Three Part Study: Part 1 Placebo-controlled, Randomised, Dose Escalating Double Blinded Within Each Dose Level; Part 2 Open Label Grapefruit Juice Effect in 100 mg Dose Level Group; Part 3 Open Label Food Effect in 400 mg Dose Level Group
Lead sponsor
Boehringer Ingelheim
Phase
Phase 1
Overall status
Completed
Start date
May 31, 2002
Completion date
Not reported
Enrollment
46 (actual)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

healthy