Study to determine bioavailablity of 300 mg aliskiren mini-tablets vs 300 mg aliskiren market tablet.
- Conditions
- HypertensionMedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-000855-15-Outside-EU/EEA
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 69
- Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Light smokers (< 5 cigarettes/ beedies per day).
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
For a full list of inclusion criteria please refer to the full protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 69
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- Participation in any clinical investigation within four (4) weeks prior to initial dosing.
- Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing.
- Hemoglobin levels below 12 gm/100mL.
- Significant illness within two (2) weeks prior to initial dosing.
For a full list of exclusion criteria please refer to the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To determine the bioavailability of a single oral dose of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjects<br>- To evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjects;Secondary Objective: To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren minitablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet without meal in healthy subjects, respectively;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not appicable