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

TheraVida, Inc.18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Incontinence

Interventions

TolterodineDRUG

Comparison of different dosages of drug

PilocarpineDRUG

Comparison of different dosages of drug

THVD-201DRUG

Comparison of different dosages of drug

THVD-201

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reductions in stimulated salivary flow (SSF)

Time frame: From Baseline

Secondary Outcomes

Determine the pharmacokinetics of tolterodine and the agonist.

Time frame: From Baseline

Data from ClinicalTrials.gov

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