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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
TheraVida, Inc.
ClinicalTrials.gov Identifier:
NCT01036035
First received: December 16, 2009
Last updated: December 17, 2009
Last verified: December 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Incontinence
 Drug: Tolterodine
Drug: Pilocarpine
Drug: THVD-201
Drug: placebo capsule
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TheraVida, Inc.:

Primary Outcome Measures:
  • Reductions in stimulated salivary flow (SSF) [ Time Frame: From Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the pharmacokinetics of tolterodine and the agonist. [ Time Frame: From Baseline ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: September 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036035

Sponsors and Collaborators
TheraVida, Inc.
Investigators
Principal Investigator: Joanne Marjason Queensland Institute for Medical Research
  More Information

No publications provided

Responsible Party: TheraVida, Inc.
ClinicalTrials.gov Identifier: NCT01036035     History of Changes
Other Study ID Numbers: THVD-201-001
Study First Received: December 16, 2009
Last Updated: December 17, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by TheraVida, Inc.:
Tolterodine
Over active Bladder (OAB)
Incontinence

Additional relevant MeSH terms:
Pilocarpine
Phenylpropanolamine
Tolterodine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
 Cholinergic Antagonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013