Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Amlodipine - reference; Drug: Amlodipine ODT - test

• Registration Number: NCT01138826
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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 (non-ODT) tablet.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-08
• Study Start: 2010-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Results First Submitted: 2011-06-21
• Results First Submitted QC: 2011-06-21
• Results First Posted: 2011-07-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment A - reference w/ water	Amlodipine - reference	-
Treatment B - ODT (test) w/ water	Amlodipine ODT - test	-
Treatment C - ODT (test) w/o water	Amlodipine ODT - test	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose	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)	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 plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
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 Outcome Measures

Name	Time	Method
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
Plasma Decay Half-Life (t1/2)	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 is the time measured for the plasma concentration to decrease by one half.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Hydrabad, Andhra Pradesh, India