Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Candesartan; Candesartan cilexetil; Nifedipine

Criteria

Inclusion Criteria:

• The informed consent form must be signed before any study specific tests or procedures are done

• Confirmation of the subject's health insurance coverage prior to the first screening visit

• Healthy male subject

• Ethnicity: Caucasian

• Age: 18 to 45 years (inclusive) at the first screening visit

• Body mass index (BMI) above or equal 18, and below or equal 29.9 kg / m²

• Ability to understand and follow study-related instructions

Exclusion Criteria:

• 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 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John's Wort)

• Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)

• examples for CYP3A inhibitors: erythromycin, inhibitors of human HIV protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine;

• examples for CYP3A inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing St. John's Wort;

• Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)

• At the first screening visit

• Diastolic blood pressure above 95 mmHg (after at least 15 min supine)

• Heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit

• Clinically relevant findings in the physical examination

• Positive urine drug screening or alcohol breath test

• Exclusion periods from other studies or simultaneous participation in other clinical studies