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

An open-label, randomized, two-period crossover study to explore the pharmacokinetics of diltiazem solution released from the IntelliCap as compared to a marketed diltiazem 60 mg extended release capsule in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45336965

Enrollment

Registered

2014-02-25

Start date

2011-12-27

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmaceutical research and development Not Applicable

Interventions

14 male, healthy volunteers at a single site will undergo both of the following interventions in a randomized order with a wash-out period in between of at least 7 days: 1. IntelliCap capsule: payloa

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent 2. Healthy male subjects age 18 to 45 years of age inclusive 3. Vital signs: body temperature between 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
1. Adverse events, adverse device effects (number, severity) 2. Physical examination: Day -1 in each period, end of study visit (> 4 days after last administration) 3. Vital signs and body measurements: body weight, oral body temperature: Day -1 in each period, end of study visit. Systolic and diastolic blood pressure and pulse rate: Day -1, pre-administration, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-administration, end of study visit (> 4 days after last administration) 4. ECG evaluation: Day -1 in each period, end of study visit (> 4 days after last administration) 5. Standard clinical laboratory evaluation (hematology: hemoglobin, hematocrit, WBC count with differential (monocytes, eosinophils, basophils, neutrophils, lymphocytes) as absolute value, RBC count and platelet count. Blood chemistry: albumin, alkaline phosphatase, bilirubin (total, direct and indirect), bicarbonate/CO2, calcium, cholesterol, chloride, creatinine, CK, gamma-GT, glucose, LDH, inorganic phosphorus, lipase, amylase, magnesium, potassium, total protein, AST, ALT, sodium, triglycerides, urea/BUN and uric acid. Urinalysis: specific gravity, pH; semi-quantitative 'dipstick' evaluation of glucose, protein, bilirubin, ketones, leukocytes, blood): Day -1 in each period, 24 h post-administration, end of study visit (> 4 days after last administration)	—

Measure

Time frame

1. Adverse events, adverse device effects (number, severity) 2. Physical examination: Day -1 in each period, end of study visit (> 4 days after last administration) 3. Vital signs and body measurements: body weight, oral body temperature: Day -1 in each period, end of study visit. Systolic and diastolic blood pressure and pulse rate: Day -1, pre-administration, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-administration, end of study visit (> 4 days after last administration) 4. ECG evaluation: Day -1 in each period, end of study visit (> 4 days after last administration) 5. Standard clinical laboratory evaluation (hematology: hemoglobin, hematocrit, WBC count with differential (monocytes, eosinophils, basophils, neutrophils, lymphocytes) as absolute value, RBC count and platelet count. Blood chemistry: albumin, alkaline phosphatase, bilirubin (total, direct and indirect), bicarbonate/CO2, calcium, cholesterol, chloride, creatinine, CK, gamma-GT, glucose, LDH, inorganic phosphorus, lipase, amylase, magnesium, potassium, total protein, AST, ALT, sodium, triglycerides, urea/BUN and uric acid. Urinalysis: specific gravity, pH; semi-quantitative 'dipstick' evaluation of glucose, protein, bilirubin, ketones, leukocytes, blood): Day -1 in each period, 24 h post-administration, end of study visit (> 4 days after last administration)

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Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026