Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Healthy Clinical Trial

Official title:

An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004614
• Other study ID #: A0531088
• Status: Completed
• Phase: Phase 1
• Start date: November 2009
• Est. completion date: December 2009

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Amlodipine
3rd OD 5 mg tablet single oral dose administered with water
• Amlodipine
2nd OD 5 mg tablet single oral dose administered with water
• Amlodipine
3rd OD 5 mg tablet single oral dose administered without water
• Amlodipine
2nd OD 5 mg tablet single oral dose administered without water

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)	Area under the concentration-time curve from zero time until the last sampling time	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Primary	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	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)	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.	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Secondary	Apparent Terminal Elimination Phase Rate Constant (Kel)	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.	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Secondary	Apparent Terminal Elimination Half-Life (T-half)	Terminal phase half-life calculated as ln(2) / kel	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Secondary	Mean Residence Time (MRT)	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.	prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Secondary	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

External Links

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