A study in healthy subjects to explore the blood levels of a drug when released from the IntelliCap capsule as compared to a marketed drug capsule
Not Applicable
Completed
- Conditions
- Pharmaceutical research and developmentNot Applicable
- Registration Number
- ISRCTN45336965
- Lead Sponsor
- Medimetrics Personalized Drug Delivery B.V. (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
1. Provision of informed consent
2. Healthy male subjects age 18 to 45 years of age inclusive
3. Vital signs: body temperaturebetween 35.0 and 37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse rate 50-90 bpm
4. Body weight > 50 kg, BMI 18 to 29 kg/m2
Exclusion Criteria
1. Smoking
2. Use of prescription drugs, herbal supplements, over the counter medication
3. Significant ECG (electrocardiogram) abnormalities
4. Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
5. Impaired renal function
6. Pacemakers or other implanted electro-medical devices
7. Swallowing disorder
8. Scheduled MRI assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of diltiazem released from the IntelliCap as compared to a marketed extended release capsule (AUClast, AUC0-t, AUC8, Cmax, Tmax, Tlag, T1/2). Blood collection for diltiazem (parent) bioanalysis: pre-administration, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 24, 36, 48 h post-administration. Diltiazem is determined in plasma by a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, lower limit of quantification (LLOQ) at 0.2 ng/mL using 200 µL plasma.
- Secondary Outcome Measures
Name Time Method