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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 49
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Nifedipine-candesartan FDC
Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
Intervention: Nifedipine-candesartan FDC (BAY 98-7106) (Drug)
Nifedipine and candesartan
Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.
Intervention: Nifedipine GITS (Adalat LA, BAYA1040) (Drug)
Nifedipine and candesartan
Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.
Intervention: Candesartan (Atacand) (Drug)
Nifedipine
Each subject received one dose of nifedipine GITS 60 mg orally.
Intervention: Nifedipine GITS (Adalat LA, BAYA1040) (Drug)
Candesartan
Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.
Intervention: Candesartan (Atacand) (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: Within 48 hours after each treatment
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
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
- AUC(Within 48 hours after each treatment)
- Cmax,norm(Within 48 hours after each treatment)
- AUCnorm(Within 48 hours after each treatment)
- AUC(0-48)(Within 48 hours after each treatment)
- tmax(Within 48 hours after each treatment)
- t½(Within 48 hours after each treatment)
- MRT(Within 48 hours after each treatment)
- CL/f(Within 48 hours after each treatment)
- Number of participants with adverse events(Approximately 3.5 months)