Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Amlodipine

• Registration Number: NCT01004614
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Study Start: 2009-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-03
• Results First Submitted QC: 2011-11-29
• Results First Posted: 2012-01-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	Amlodipine	24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water.
Cohort 2	Amlodipine	24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose	Area under the concentration-time curve from zero time until the last sampling time
Maximum Observed Plasma Concentration (Cmax)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Secondary Outcome Measures

Name	Time	Method
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)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose	AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.; AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration.
Apparent Terminal Elimination Phase Rate Constant (Kel)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose	Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.
Apparent Terminal Elimination Half-Life (T-half)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose	Terminal phase half-life calculated as ln(2) / kel
Mean Residence Time (MRT)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose	MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel\^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Minato-ku, Tokyo, Japan