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Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects

NCT ID: NCT01036035

Last Updated: 2015-12-30

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Detailed Description

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Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.

Conditions

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Incontinence

Keywords

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Tolterodine Over active Bladder (OAB) Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment B

Study drug

Group Type ACTIVE_COMPARATOR

Pilocarpine

Intervention Type DRUG

Comparison of different dosages of drug

Treatment D

Study drug

Group Type ACTIVE_COMPARATOR

THVD-201

Intervention Type DRUG

Comparison of different dosages of drug

Treatment E

Placebo

Group Type PLACEBO_COMPARATOR

placebo capsule

Intervention Type DRUG

Comparison of different dosages of drug

Treatment A

Study Drug

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

Comparison of different dosages of drug

Treatment C

Study Drug

Group Type ACTIVE_COMPARATOR

THVD-201

Intervention Type DRUG

Comparison of different dosages of drug

Interventions

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Tolterodine

Comparison of different dosages of drug

Intervention Type DRUG

Pilocarpine

Comparison of different dosages of drug

Intervention Type DRUG

THVD-201

Comparison of different dosages of drug

Intervention Type DRUG

THVD-201

Comparison of different dosages of drug

Intervention Type DRUG

placebo capsule

Comparison of different dosages of drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males, 18 - 45 years of age.
* BMI 20-30 m2.

Exclusion Criteria

* Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
* Clinically significant ECG, vital signs and clinical laboratory indices.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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TheraVida, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Marjason

Role: PRINCIPAL_INVESTIGATOR

Queensland Institute for Medical Research

Other Identifiers

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THVD-201-001

Identifier Type: -

Identifier Source: org_study_id