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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014