Trial Outcomes & Findings for Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets (NCT NCT01138826)
NCT ID: NCT01138826
Last Updated: 2021-01-28
Results Overview
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water
Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT
Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet
Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water
Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT
Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet
Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|---|---|---|
|
First Intervention Period
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention Period
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period I (of 16 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout Period I (of 16 Days)
COMPLETED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Washout Period I (of 16 Days)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
1
|
0
|
|
Second Intervention Period
STARTED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Second Intervention Period
COMPLETED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period II (of 16 Days)
STARTED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Washout Period II (of 16 Days)
COMPLETED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Washout Period II (of 16 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention Period
STARTED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Third Intervention Period
COMPLETED
|
2
|
2
|
3
|
3
|
2
|
3
|
|
Third Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water
Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT
Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet
Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water
Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT
Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
|
Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet
Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|---|---|---|
|
Washout Period I (of 16 Days)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=18 Participants
All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
|
|---|---|
|
Age, Continuous
|
27.22 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours 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.
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Outcome measures
| Measure |
Amlodipine 10mg Tablet With Water (Reference Product A)
n=17 Participants
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water \[Reference product A\]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water \[Test product B\]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water \[Test product C\]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT With Water (Test Product B)
n=15 Participants
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT Without Water (Test Product C)
n=16 Participants
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
|
307.225 hr*ng/mL
Interval 61.736 to 468.617
|
324.324 hr*ng/mL
Interval 48.0 to 554.452
|
330.411 hr*ng/mL
Interval 54.526 to 687.254
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours 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 time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Outcome measures
| Measure |
Amlodipine 10mg Tablet With Water (Reference Product A)
n=17 Participants
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water \[Reference product A\]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water \[Test product B\]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water \[Test product C\]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT With Water (Test Product B)
n=15 Participants
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT Without Water (Test Product C)
n=16 Participants
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|
|
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
|
275.302 hr*ng/mL
Interval 60.422 to 439.855
|
285.974 hr*ng/mL
Interval 46.48 to 439.395
|
287.035 hr*ng/mL
Interval 52.378 to 482.589
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours 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 |
Amlodipine 10mg Tablet With Water (Reference Product A)
n=17 Participants
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water \[Reference product A\]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water \[Test product B\]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water \[Test product C\]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT With Water (Test Product B)
n=15 Participants
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT Without Water (Test Product C)
n=16 Participants
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
5.201 ng/mL
Interval 1.88 to 9.35
|
5.117 ng/mL
Interval 1.41 to 7.4
|
4.952 ng/mL
Interval 1.5 to 7.02
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours 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 |
Amlodipine 10mg Tablet With Water (Reference Product A)
n=17 Participants
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water \[Reference product A\]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water \[Test product B\]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water \[Test product C\]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT With Water (Test Product B)
n=15 Participants
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT Without Water (Test Product C)
n=16 Participants
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
8.00 hr
Interval 6.0 to 16.0
|
10.00 hr
Interval 6.0 to 16.0
|
13.00 hr
Interval 6.0 to 14.0
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours 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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Amlodipine 10mg Tablet With Water (Reference Product A)
n=17 Participants
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water \[Reference product A\]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water \[Test product B\]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water \[Test product C\]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT With Water (Test Product B)
n=15 Participants
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
Amlodipine 10 mg ODT Without Water (Test Product C)
n=16 Participants
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
|
|---|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
44.004 hr
Standard Deviation 13.759
|
46.698 hr
Standard Deviation 14.739
|
49.869 hr
Standard Deviation 19.638
|
Adverse Events
Amlodipine 10mg Tablet With Water (Reference Product A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amlodipine 10 mg ODT With Water (Test Product B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amlodipine 10 mg ODT Without Water (Test Product C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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