Trial Outcomes & Findings for This Is A Study Of Bioavailability And Food Effect For Fesoterodine. (NCT NCT01286454)
NCT ID: NCT01286454
Last Updated: 2012-01-26
Results Overview
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose
Results posted on
2012-01-26
Participant Flow
Participant milestones
| Measure |
Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER
Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER
Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER
Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
|
Fesoterodine 4 mg 10% ER Fed
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
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|---|---|---|---|---|---|---|---|---|---|---|---|
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Part I- First Intervention Period
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Part I- First Intervention Period
COMPLETED
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2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Part I- First Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Washout Period (At Least 3 Days)
STARTED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Washout Period (At Least 3 Days)
COMPLETED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Washout Period (At Least 3 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Second Intervention Period
STARTED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Second Intervention Period
COMPLETED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Second Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Third Intervention Period
STARTED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Third Intervention Period
COMPLETED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Third Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Fourth Intervention Period
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Fourth Intervention Period
COMPLETED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Fourth Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Fifth Intervention Period
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Fifth Intervention Period
COMPLETED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Fifth Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Washout Period (Approximately 2 Weeks)
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Washout Period (Approximately 2 Weeks)
COMPLETED
|
2
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2
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Washout Period (Approximately 2 Weeks)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part II- Sixth Intervention Period
STARTED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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20
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Part II- Sixth Intervention Period
COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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20
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Part II- Sixth Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
|
|---|---|
|
Age Continuous
|
39.5 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dosePopulation: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
Fesoterodine 4 mg IR-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 15% ER-BIC Fasted
n=16 Participants
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 20% ER-BIC Fasted
n=4 Participants
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg ER Tablet Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fed
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
|
30.48 ng*hr/mL
Standard Deviation 11.77
|
28.24 ng*hr/mL
Standard Deviation 10.35
|
19.64 ng*hr/mL
Standard Deviation 7.58
|
NA ng*hr/mL
Standard Deviation NA
Parameter was missing for more than 50 percent of the participants.
|
27.40 ng*hr/mL
Standard Deviation 10.06
|
32.07 ng*hr/mL
Standard Deviation 13.24
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Outcome measures
| Measure |
Fesoterodine 4 mg IR-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 15% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 20% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg ER Tablet Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fed
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
|
30.23 ng*hr/mL
Standard Deviation 11.79
|
27.79 ng*hr/mL
Standard Deviation 10.21
|
17.92 ng*hr/mL
Standard Deviation 6.95
|
7.59 ng*hr/mL
Standard Deviation 3.57
|
26.80 ng*hr/mL
Standard Deviation 10.07
|
31.88 ng*hr/mL
Standard Deviation 13.24
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Fesoterodine 4 mg IR-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 15% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 20% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg ER Tablet Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fed
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
|
5.830 ng/mL
Standard Deviation 2.729
|
3.030 ng/mL
Standard Deviation 1.068
|
1.092 ng/mL
Standard Deviation 0.496
|
0.323 ng/mL
Standard Deviation 0.183
|
2.247 ng/mL
Standard Deviation 1.000
|
5.183 ng/mL
Standard Deviation 1.919
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Fesoterodine 4 mg IR-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 15% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 20% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg ER Tablet Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fed
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)
|
1.0 hr
Interval 0.5 to 5.0
|
6.0 hr
Interval 5.0 to 8.0
|
6.0 hr
Interval 5.0 to 10.0
|
8.0 hr
Interval 5.0 to 24.0
|
5.0 hr
Interval 2.0 to 6.0
|
4.0 hr
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Fesoterodine 4 mg IR-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 15% ER-BIC Fasted
n=16 Participants
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 20% ER-BIC Fasted
n=4 Participants
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg ER Tablet Fasted
n=20 Participants
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fed
n=20 Participants
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
|
|---|---|---|---|---|---|---|
|
Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)
|
5.56 hr
Standard Deviation 1.70
|
7.22 hr
Standard Deviation 1.68
|
10.89 hr
Standard Deviation 4.45
|
NA hr
Standard Deviation NA
Parameter was missing for more than 50 percent of the participants.
|
7.54 hr
Standard Deviation 2.49
|
4.59 hr
Standard Deviation 0.76
|
Adverse Events
Fesoterodine 4 mg IR-BIC Fasted
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Fesoterodine 4 mg 10% ER-BIC Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fesoterodine 4 mg 15% ER-BIC Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Fesoterodine 4 mg 20% ER-BIC Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fesoterodine 4 mg ER Tablet Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fesoterodine 4 mg 10% ER-BIC Fed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fesoterodine 4 mg IR-BIC Fasted
n=20 participants at risk
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fasted
n=20 participants at risk
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 15% ER-BIC Fasted
n=20 participants at risk
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 20% ER-BIC Fasted
n=20 participants at risk
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg ER Tablet Fasted
n=20 participants at risk
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
|
Fesoterodine 4 mg 10% ER-BIC Fed
n=20 participants at risk
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling cold
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vessel puncture site haematoma
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vessel puncture site pain
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.0%
3/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.0%
3/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER