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Nifedipine gastrointestinal therapeutic system+ Candesartan cilexetil

Phase 1

Clinical Pharmacology | Small molecule | Other |Bayer AG|Last Updated: May 2, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Nifedipine gastrointestinal therapeutic system+ Candesartan cilexetil · 1 trial · 1 indication

Phase 1 1
NCT03136666Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.Clinical Pharmacology
COMPLETED12 Analytics
PHASE1COMPLETED
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
Clinical Pharmacology
NCT0313666612
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Study Endpoints

Primary Endpoints

Overall summary of adverse events as a measure of safety and tolarability
7 weeks

Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events.

Safety related laboratory findings
7 weeks

Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal.

Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)
48 hours
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)
48 hours

Secondary Endpoints

Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)
48 hours
Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)
48 hours
Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))
48 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nifedipine + Candesartan cilexetilEXPERIMENTALCoadministration of single doses of nifedipine and candesartan tablets

Interventions

NameTypeDescription
Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetilDRUGCandesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours.
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Eligibility Criteria

Age Range30 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male volunteers * Age 30-55 years * BMI 18.0-29.9 kg/m² * Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg

Countries:Germany
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