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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment B | Active Comparator | Study drug |
|
| Treatment D | Active Comparator | Study drug |
|
| Treatment E | Placebo Comparator | Placebo |
|
| Treatment A | Active Comparator | Study Drug |
|
| Treatment C | Active Comparator | Study Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine | Drug | Comparison of different dosages of drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reductions in stimulated salivary flow (SSF) | From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the pharmacokinetics of tolterodine and the agonist. | From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Marjason | Queensland Institute for Medical Research | Principal Investigator |
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| Pilocarpine |
| Drug |
Comparison of different dosages of drug |
|
| THVD-201 | 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 |
|
| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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