Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
This study has been completed.
Sponsor:
Pfizer
Collaborators:
Aurobindo Pharma Limited
Trident Life Sciences Limited
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01138826
First received: March 8, 2010
Last updated: June 21, 2011
Last verified: June 2011
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Purpose
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 (non-ODT) tablet.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Amlodipine - reference Drug: Amlodipine ODT - test |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Tablets Manufactured by Pfizer Illertissen, Germany Under Fasted Conditions |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose ] [ Designated as safety issue: No ]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-∞).
- AUC From Time Zero to Last Quantifiable 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 ] [ Designated as safety issue: No ]Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose ] [ Designated as safety issue: No ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| Enrollment: | 18 |
| Study Start Date: | May 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: treatment A - reference w/ water |
Drug: Amlodipine - reference
10 mg tablet, single dose, with water
|
| Experimental: Treatment B - ODT (test) w/ water |
Drug: Amlodipine ODT - test
10 mg orally disintegrating tablet (ODT), single dose, with water
|
| Experimental: Treatment C - ODT (test) w/o water |
Drug: Amlodipine ODT - test
10 mg orally disintegrating tablet (ODT), single dose, without water
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and/or female subjects (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).
- Body Mass Index (BMI) of 18 to 26 kg/m2; 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).
- A positive urine drug screen.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138826
Locations
| India | |
| Pfizer Investigational Site | |
| Hydrabad, Andhra Pradesh, India, 500 050 | |
Sponsors and Collaborators
Pfizer
Aurobindo Pharma Limited
Trident Life Sciences Limited
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01138826 History of Changes |
| Other Study ID Numbers: | A0531095, 051-10 |
| Study First Received: | March 8, 2010 |
| Results First Received: | June 21, 2011 |
| Last Updated: | June 21, 2011 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by Pfizer:
|
biological availability bioavailability amlodipine |
orally disintegrating tablet ODT tablets |
Additional relevant MeSH terms:
|
Amlodipine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 19, 2013