Pharmacokinetics and Relative Bioavailability Study

Viatris

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder, Overactive

Treatments: Drug: tolterodine tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521767

A6121196

Details and patient eligibility

About

A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules

Full description

Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules

Enrollment: 16 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Exclusion criteria

• Evidence or history of clinically significant diseases

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 5 patient groups

A

Experimental group

Description:

4 mg tolterodine extended release capsules, administered with water and under fasting condition.

Treatment:

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

B

Experimental group

Description:

4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.

Treatment:

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

C

Experimental group

Description:

4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.

Treatment:

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

D

Experimental group

Description:

4 mg MPB-RR1, administered without water and under fed condition.

Treatment:

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

E

Experimental group

Description:

4 mg MPB-RR1, administered with water and under fasting condition.

Treatment:

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate

Drug: tolterodine tartrate