Phase 1
Completed N=26
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
Healthy
Source: ClinicalTrials.gov NCT01151345 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] — 463.41; 498.87 ng*hr/mL
Summary
This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] |
463.41; 498.87 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
612.95; 648.68 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
68.67; 79.60 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.38; 2.44 | — |
| PRIMARY Plasma Decay Half-Life (t1/2) |
12.17; 11.71 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Both genders
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 or ± 10% variation of the ideal weight; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen
Data sourced from ClinicalTrials.gov (NCT01151345). 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. Informational only — not medical advice.