Trial Outcomes & Findings for Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules (NCT NCT01177293)

NCT ID: NCT01177293

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

14 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

Participant milestones
Measure	Amlodipine Capsule Then Amlodipine ODT Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.	Amlodipine ODT Then Amlodipine Capsule Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
First Intervention Period STARTED	7	7
First Intervention Period COMPLETED	7	7
First Intervention Period NOT COMPLETED	0	0
Washout Period (of 14 Days) STARTED	7	7
Washout Period (of 14 Days) COMPLETED	7	6
Washout Period (of 14 Days) NOT COMPLETED	0	1
Second Intervention Period STARTED	7	6
Second Intervention Period COMPLETED	7	6
Second Intervention Period NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Amlodipine Capsule Then Amlodipine ODT Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.	Amlodipine ODT Then Amlodipine Capsule Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
Washout Period (of 14 Days) Lost to Follow-up	0	1

Baseline Characteristics

Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=14 Participants Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
Age, Continuous	25.00 years STANDARD_DEVIATION 6.36 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 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 dose

Population: 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

Outcome measures
Measure	Amlodipine 10 mg Capsule n=12 Participants Single oral dose of amlodipine 10 mg capsule (Treatment A \[Reference\]).	Amlodipine 10 mg ODT n=13 Participants Single oral dose of amlodipine 10 mg ODT (Treatment B \[Test\]).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	401.655 hr*ng/mL Interval 61.74 to 566.54	360.619 hr*ng/mL Interval 266.76 to 635.54

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

Population: 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

Outcome measures
Measure	Amlodipine 10 mg Capsule n=12 Participants Single oral dose of amlodipine 10 mg capsule (Treatment A \[Reference\]).	Amlodipine 10 mg ODT n=13 Participants Single oral dose of amlodipine 10 mg ODT (Treatment B \[Test\]).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	331.300 hr*ng/mL Interval 60.42 to 463.69	330.394 hr*ng/mL Interval 243.87 to 558.6

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

Population: 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

Outcome measures
Measure	Amlodipine 10 mg Capsule n=12 Participants Single oral dose of amlodipine 10 mg capsule (Treatment A \[Reference\]).	Amlodipine 10 mg ODT n=13 Participants Single oral dose of amlodipine 10 mg ODT (Treatment B \[Test\]).
Maximum Observed Plasma Concentration (Cmax)	6.427 ng/mL Interval 1.88 to 8.32	5.571 ng/mL Interval 3.92 to 7.84

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Population: 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

Outcome measures
Measure	Amlodipine 10 mg Capsule n=12 Participants Single oral dose of amlodipine 10 mg capsule (Treatment A \[Reference\]).	Amlodipine 10 mg ODT n=13 Participants Single oral dose of amlodipine 10 mg ODT (Treatment B \[Test\]).
Time to Reach Maximum Observed Plasma Concentration (Tmax)	8.00 hr Interval 6.0 to 14.0	10.00 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 dose

Population: 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

Outcome measures
Measure	Amlodipine 10 mg Capsule n=12 Participants Single oral dose of amlodipine 10 mg capsule (Treatment A \[Reference\]).	Amlodipine 10 mg ODT n=13 Participants Single oral dose of amlodipine 10 mg ODT (Treatment B \[Test\]).
Plasma Decay Half-life (t1/2)	51.374 hr Standard Deviation 12.912	45.120 hr Standard Deviation 4.921

Adverse Events

Amlodipine 10 mg Capsule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amlodipine 10 mg ODT

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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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