A Phase 1 interventional study of Amlodipine - reference and Amlodipine ODT - test in Healthy Volunteers, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Basic science
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Amlodipine - reference
Drug: Amlodipine ODT - test
Amlodipine capsule, 10 mg, single dose, with water
Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
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-∞).
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Plasma Decay Half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
| Milestone | Amlodipine Capsule Then Amlodipine ODT | Amlodipine ODT Then Amlodipine Capsule |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | Amlodipine Capsule Then Amlodipine ODT | Amlodipine ODT Then Amlodipine Capsule |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Amlodipine Capsule Then Amlodipine ODT | Amlodipine ODT Then Amlodipine Capsule |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 6 |
| Not completed | 0 | 0 |
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-∞).
| hr*ng/mL | Amlodipine 10 mg Capsule | Amlodipine 10 mg ODT |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | 401.655 (61.74 to 566.54) | 360.619 (266.76 to 635.54) |
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
| hr*ng/mL | Amlodipine 10 mg Capsule | Amlodipine 10 mg ODT |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 331.300 (60.42 to 463.69) | 330.394 (243.87 to 558.60) |
| ng/mL | Amlodipine 10 mg Capsule | Amlodipine 10 mg ODT |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 6.427 (1.88 to 8.32) | 5.571 (3.92 to 7.84) |
| hr | Amlodipine 10 mg Capsule | Amlodipine 10 mg ODT |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 8.00 (6.00 to 14.00) | 10.00 (6.00 to 14.00) |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| hr | Amlodipine 10 mg Capsule | Amlodipine 10 mg ODT |
|---|---|---|
| Plasma Decay Half-life (t1/2) | 51.374 ± 12.912 | 45.120 ± 4.921 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amlodipine 10 mg Capsule | — | 0/14 (0%) | 0/14 (0%) |
| Amlodipine 10 mg ODT | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 25.00 ± 6.36 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 0 |
| Male | 14 |
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.