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

T

TheraVida, Inc.

Status and phase

Completed
Phase 1

Conditions

Incontinence

Treatments

Drug: THVD-201
Drug: Pilocarpine
Drug: placebo capsule
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

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
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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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