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Completed

NCT Number: NCT01004614

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

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.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine

Drug

3rd OD 5 mg tablet single oral dose administered with water

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 30, 2009
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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