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Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Action-

Mechanism-

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Boehringer Ingelheim International GmbH

Active Organization-

Inactive Organization

Boehringer Ingelheim GmbH

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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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

The objectives are:
To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses.
To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice.
To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g fat and high caloric breakfast.

Start Date01 May 2002

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with BIRT-1696-BS

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100 Translational Medicine associated with BIRT-1696-BS

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100 Patents (Medical) associated with BIRT-1696-BS

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100 Deals associated with BIRT-1696-BS

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