Trial Profile
Administration of ESR 1150 CL in Ascending Doses of 0.5, 1, 2, 4 and 8 mg in an Open, Group Comparison and Placebo-controlled Design (Placebo Randomised Double Blind in the Dose Groups) for the Assessment of Safety, Tolerability (Maximum Tolerated Dose, MTD), Pharmacokinetics and Pharmacodynamics in 5 Groups of 8 Female and 5 Male Healthy Subjects, and 4 mg Additionally in Fed State, in a Cross Over Design. Safety, Tolerability and Pharmacokinetics of MTD/4, MTD/2 and MTD in 6 Healthy Male Subjects, Identified as CYP2D6 and/or "Spartein" Poor Metabolizers, in a 3-fold Cross Over, Open Study.
Status:
Discontinued
Phase of Trial:
Phase I
Latest Information Update: 17 Sep 2021
Price :
$35
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At a glance
- Drugs ESR 1150 CL (Primary)
- Indications Urinary incontinence
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
- Sponsors Boehringer Ingelheim
- 08 Aug 2014 New trial record