We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004614
First Posted: October 30, 2009
Last Update Posted: January 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
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

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 ]
    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 ]

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 ]

    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 ]
    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 ]
    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 ]
    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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01004614     History of Changes
Other Study ID Numbers: A0531088
First Submitted: October 29, 2009
First Posted: October 30, 2009
Results First Submitted: December 3, 2010
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