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

Bayer

Status and phase

Completed

Phase 1

Conditions

Hypertension, Essential

Treatments

Drug: Nifedipine/Candesartan (BAY 98-7106)

Drug: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01350609

14028

2011-000322-29 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Clinical pharmacology

Enrollment

49 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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