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CompletedNCT01036035Updated Dec 30, 2015

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

A Phase 1 interventional study of Tolterodine and Pilocarpine in Incontinence, sponsored by TheraVida, Inc.. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by TheraVida, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Incontinence

Keywords

  • Tolterodine
  • Over active Bladder (OAB)
  • Incontinence
03

In context

Lead sponsor

This is the only study on the registry with TheraVida, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Treatment B

    Study drug

    Drug: Pilocarpine

  • Active comparator
    Treatment D

    Study drug

    Drug: THVD-201

  • Placebo comparator
    Treatment E

    Placebo

    Drug: placebo capsule

  • Active comparator
    Treatment A

    Study Drug

    Drug: Tolterodine

  • Active comparator
    Treatment C

    Study Drug

    Drug: THVD-201

Interventions

  • DrugTolterodine

    Comparison of different dosages of drug

  • DrugPilocarpine

    Comparison of different dosages of drug

  • DrugTHVD-201

    Comparison of different dosages of drug

  • DrugTHVD-201

    Comparison of different dosages of drug

  • Drugplacebo capsule

    Comparison of different dosages of drug

06

What researchers measure

Primary outcomes

  1. Reductions in stimulated salivary flow (SSF)

    Time frame: From Baseline

Secondary outcomes

  1. Determine the pharmacokinetics of tolterodine and the agonist.

    Time frame: From Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01036035
Lead sponsor
TheraVida, Inc.
Responsible party
Sponsor
First posted
Dec 21, 2009
Start date
Sep 2009
Primary completion
Mar 2010
Completion
Apr 2010
Last update
Dec 30, 2015

Study contacts

Joanne Marjason
principal investigator · Queensland Institute for Medical Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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