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14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man

NCT ID: NCT01176201

Last Updated: 2011-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-10-31

Brief Summary

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This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

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Detailed Description

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The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

400 mg suspension

Group Type EXPERIMENTAL

SLV337 suspension

Intervention Type DRUG

400 mg experimental

B

5 x 200 mg immediate release capsule

Group Type ACTIVE_COMPARATOR

SLV337 capsule

Intervention Type DRUG

5 x 200 mg immediate release capsule

Interventions

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SLV337 suspension

400 mg experimental

Intervention Type DRUG

SLV337 capsule

5 x 200 mg immediate release capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 18 - 28 kg/m2
* SBP 90-140
* DBP 50-90

Exclusion Criteria

* Seizures,
* Orthostatic hypotension
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anita Vanderlaan

Role: STUDY_DIRECTOR

Abbott Healthcare Products BV

Locations

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Site Reference ID/Investigator# 61345

Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2010-020006-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S337.1.005

Identifier Type: -

Identifier Source: org_study_id

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