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

TheraVida

Status and phase: Completed; Phase 1

Conditions: Incontinence

Treatments: Drug: placebo capsule; Drug: THVD-201; Drug: Pilocarpine; Drug: Tolterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01036035

THVD-201-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 5 patient groups, including a placebo group

Treatment B

Active Comparator group

Description:

Study drug

Treatment:

Drug: Pilocarpine

Treatment D

Active Comparator group

Description:

Study drug

Treatment:

Drug: THVD-201

Drug: THVD-201

Treatment E

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo capsule

Treatment A

Active Comparator group

Description:

Study Drug

Treatment:

Drug: Tolterodine

Treatment C

Active Comparator group

Description:

Study Drug

Treatment:

Drug: THVD-201

Drug: THVD-201