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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TheraVida, Inc.
ClinicalTrials.gov Identifier:
NCT01036035
First received: December 16, 2009
Last updated: December 28, 2015
Last verified: December 2015
  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:


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
Study Completion Date: April 2010
Primary Completion Date: March 2010 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 28, 2015
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
Tolterodine Tartrate
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents

ClinicalTrials.gov processed this record on December 02, 2016