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

Healthy Volunteers Clinical Trial

Official title:

Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manufactured By Pfizer France Under Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177293
• Other study ID #: A0531096
• Secondary ID: 052-10
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female literate 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 17.5 to 26.4 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Amlodipine - reference
Amlodipine capsule, 10 mg, single dose, with water
• Amlodipine ODT - test
Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Hydrabad	Andhra Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Aurobindo Pharma Ltd, Trident Life Sciences Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-8)]	AUC (0-8) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-8). It is obtained from AUC (0-t) plus AUC (t-8).	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Primary	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).	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Secondary	Plasma Decay Half-life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

External Links

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