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

Incontinence Clinical Trial

Official title:

Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036035
• Other study ID #: THVD-201-001
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2009
• Last updated: December 28, 2015
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: December 2015
• Source: TheraVida, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incontinence

Intervention

Drug:
• Tolterodine
Comparison of different dosages of drug
• Pilocarpine
Comparison of different dosages of drug
• THVD-201
Comparison of different dosages of drug
• THVD-201
Comparison of different dosages of drug
• placebo capsule
Comparison of different dosages of drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TheraVida, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in stimulated salivary flow (SSF)		From Baseline	No
Secondary	Determine the pharmacokinetics of tolterodine and the agonist.		From Baseline	Yes