NCT01036035

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: TheraVida, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Incontinence

Interventions

Type	Name	Description
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	THVD-201	Comparison of different dosages of drug
DRUG	placebo capsule	Comparison of different dosages of drug

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2009-12-21
• Last updated: 2015-12-30