Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
Study Details
Study Description
Brief Summary
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Treatment B Study drug |
Drug: Pilocarpine
Comparison of different dosages of drug
|
Active Comparator: Treatment D Study drug |
Drug: THVD-201
Comparison of different dosages of drug
|
Placebo Comparator: Treatment E Placebo |
Drug: placebo capsule
Comparison of different dosages of drug
|
Active Comparator: Treatment A Study Drug |
Drug: Tolterodine
Comparison of different dosages of drug
|
Active Comparator: Treatment C Study Drug |
Drug: THVD-201
Comparison of different dosages of drug
|
Outcome Measures
Primary Outcome Measures
- Reductions in stimulated salivary flow (SSF) [From Baseline]
Secondary Outcome Measures
- Determine the pharmacokinetics of tolterodine and the agonist. [From Baseline]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- TheraVida, Inc.
Investigators
- Principal Investigator: Joanne Marjason, Queensland Institute for Medical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- THVD-201-001