Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01004614
First received: October 29, 2009
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Amlodipine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]
    Area under the concentration-time curve from zero time until the last sampling time

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]

    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) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]
    Terminal phase half-life calculated as ln(2) / kel

  • Mean Residence Time (MRT) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
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.
Drug: Amlodipine
3rd OD 5 mg tablet single oral dose administered with water
Drug: Amlodipine
2nd OD 5 mg tablet single oral dose administered with water
Active Comparator: Cohort 2
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
Drug: Amlodipine
3rd OD 5 mg tablet single oral dose administered without water
Drug: Amlodipine
2nd OD 5 mg tablet single oral dose administered without water

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004614

Locations
Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01004614     History of Changes
Other Study ID Numbers: A0531088
Study First Received: October 29, 2009
Results First Received: December 3, 2010
Last Updated: November 29, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 April 17, 2014