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OpenTrials
Completed

NCT Number: NCT01036035

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

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

Completed

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Key information

Conditions

Incontinence

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tolterodine

Drug

Comparison of different dosages of drug

Pilocarpine

Drug

Comparison of different dosages of drug

THVD-201

Drug

Comparison of different dosages of drug

Placebo capsule

Drug

Comparison of different dosages of drug

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

Sponsors and collaborators

Lead sponsor

TheraVida, Inc.

Industry

Registry information

Official study title

Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 21, 2009
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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