Phase 1
N=48
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01004614 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt) — 126.36; 129.48; 122.33; 119.75 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Amlodipine (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt) |
126.36; 129.48; 122.33; 119.75 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
2.70; 2.74; 2.48; 2.45 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf) |
124.14; 127.36; 121.05; 118.27; 142.87; 145.22 | — |
| SECONDARY Apparent Terminal Elimination Phase Rate Constant (Kel) |
0.0174; 0.0179; 0.0162; 0.0156 | — |
| SECONDARY Apparent Terminal Elimination Half-Life (T-half) |
41.45; 40.27; 45.04; 46.20 | — |
| SECONDARY Mean Residence Time (MRT) |
61.29; 59.77; 66.18; 67.33 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
8; 8; 8; 8 | — |
Summary
This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.
Eligibility Criteria
Inclusion Criteria
- Healthy;
- Body Mass Index (BMI) of 18 to 28 kg/m2;
- total body weight within the range of 50 to 100 kg
Exclusion Criteria
- History of regular alcohol consumption exceeding 14 drinks/week
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day
Data sourced from ClinicalTrials.gov (NCT01004614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.