Incontinence
Conditions
Keywords
Tolterodine, Over active Bladder (OAB), Incontinence
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.
Interventions
DRUGplacebo capsule
Comparison of different dosages of drug
DRUGTolterodine
Comparison of different dosages of drug
DRUGPilocarpine
Comparison of different dosages of drug
DRUGTHVD-201
Comparison of different dosages of drug
Sponsors
TheraVida, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reductions in stimulated salivary flow (SSF) | From Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Determine the pharmacokinetics of tolterodine and the agonist. | From Baseline |
Outcome results
None listed