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Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

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ClinicalTrials.gov Identifier: NCT01004614
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : January 4, 2012
Last Update Posted : January 4, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Amlodipine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    Area under the concentration-time curve from zero time until the last sampling time

  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]

    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.


  2. 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 ]
    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.

  3. 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 ]
    Terminal phase half-life calculated as ln(2) / kel

  4. 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 ]
    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.

  5. 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 ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004614


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01004614     History of Changes
Other Study ID Numbers: A0531088
First Posted: October 30, 2009    Key Record Dates
Results First Posted: January 4, 2012
Last Update Posted: January 4, 2012
Last Verified: November 2011

Additional relevant MeSH terms:
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents