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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

December 16, 2009
December 17, 2009
September 2009
December 2009   (final data collection date for primary outcome measure)
Reductions in stimulated salivary flow (SSF) [ Time Frame: From Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01036035 on ClinicalTrials.gov Archive Site
Determine the pharmacokinetics of tolterodine and the agonist. [ Time Frame: From Baseline ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Incontinence
  • Drug: Tolterodine
    Comparison of different dosages of drug
  • Drug: Pilocarpine
    Comparison of different dosages of drug
  • Drug: THVD-201
    Comparison of different dosages of drug
  • Drug: placebo capsule
    Comparison of different dosages of drug
  • Active Comparator: Treatment B
    Study drug
    Intervention: Drug: Pilocarpine
  • Active Comparator: Treatment D
    Study drug
    Intervention: Drug: THVD-201
  • Placebo Comparator: Treatment E
    Placebo
    Intervention: Drug: placebo capsule
  • Active Comparator: Treatment A
    Study Drug
    Intervention: Drug: Tolterodine
  • Active Comparator: Treatment C
    Study Drug
    Intervention: Drug: THVD-201
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
18
March 2010
December 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01036035
THVD-201-001
Yes
TheraVida, Inc.
TheraVida, Inc.
Not Provided
Principal Investigator: Joanne Marjason Queensland Institute for Medical Research
TheraVida, Inc.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP