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Completed

NCT Number: NCT01227603

Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions

Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs

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Key information

Conditions

Hypertension, Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cologne, North Rhine-Westphalia, 51063, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first screening / examination visit
  • Ethnicity: Caucasian
  • Body mass index (BMI): >/=18 and </=29,9 kg/m²

Exclusion criteria

  • Systolic blood pressure below 120 or above 145 mmHg
  • Diastolic blood pressure above 95 mmHg
  • Heart rate below 45 or above 95 beats / min
  • Clinically relevant findings in the physical examination
  • Suspicion of drug or alcohol abuse
  • Regular daily consumption of more than 1 L of xanthin-containing beverages
  • Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination

Treatment and study plan

Nifedipine-candesartan FDC (BAY 98-7106)

Drug

Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan

Nifedipine GITS (Adalat LA, BAYA1040)

Drug

Single oral dose of 1 tablet of nifedipine GITS 60 mg

Candesartan (Atacand)

Drug

Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

Primary outcomes

  1. Cmax

    Time frame: Within 48 hours after each treatment

    Maximum drug concentration in plasma after dose administration for nifedipine and candesartan

  2. AUC(0-tn)

    Time frame: Within 48 hours after each treatment

    AUC from time 0 to the last data point for nifedipine and candesartan

Secondary outcomes

  1. AUC

    Time frame: Within 48 hours after each treatment

    Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan

  2. Cmax,norm

    Time frame: Within 48 hours after each treatment

    Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan

  3. AUCnorm

    Time frame: Within 48 hours after each treatment

    Area under the curve divided by dose per kg body weight for nifedipine and candesartan

  4. AUC(0-48)

    Time frame: Within 48 hours after each treatment

    AUC from time 0 to time 48 h for nifedipine and candesartan

  5. tmax

    Time frame: Within 48 hours after each treatment

    Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan

  6. t½

    Time frame: Within 48 hours after each treatment

    Half-life associated with the terminal slope for nifedipine and candesartan

  7. MRT

    Time frame: Within 48 hours after each treatment

    Mean residence time for nifedipine and candesartan

  8. CL/f

    Time frame: Within 48 hours after each treatment

    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan

  9. Number of participants with adverse events

    Time frame: Approximately 3.5 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 25, 2010
Registry last updated
Dec 10, 2015

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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