Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
Phase 1
Completed
- Conditions
- Incontinence
- Interventions
- Registration Number
- NCT01036035
- Lead Sponsor
- TheraVida, Inc.
- Brief Summary
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment D THVD-201 Study drug Treatment E placebo capsule Placebo Treatment C THVD-201 Study Drug Treatment B Pilocarpine Study drug Treatment A Tolterodine Study Drug
- Primary Outcome Measures
Name Time Method Reductions in stimulated salivary flow (SSF) From Baseline
- Secondary Outcome Measures
Name Time Method Determine the pharmacokinetics of tolterodine and the agonist. From Baseline