Relative Bioavailability Study With Enalapril in Healthy Volunteers
Information source: Ethicare GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Enalapril (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Ethicare GmbH Official(s) and/or principal investigator(s):
Jan De Hoon, Professor, Principal Investigator, Affiliation: Center of Clinical Pharmacology, University Hospital Leuven, Leuven, Belgium
Summary
Phase I study in healthy adult male and female volunteers to compare the bioavailability of
enalapril administered in orodispersible Minitablets with or without water in comparison to
the standard galenic tablet formulation of enalapril. The standard pharmacokinetic
parameters will be calculated from the bioanalytical results for enalapril and enalaprilat
and compared in a descriptive statistical analysis.
Clinical Details
Official title: Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC 0-∞
Secondary outcome: Safety parametersTolerability Outcome Parameter AUC 0-∞ AUC 0-t AUC 0-t Cmax Cmax tmax tmax Ae
Detailed description:
Trial design: Open label, randomized, 3-way cross-over, 3-treatments, 3-periods in 24
healthy male and female adult subjects.
Primary objectives:
1. To assess the relative bioavailability of 10 mg enalapril administered as
orodispersible minitablets (ODMT) with water versus a standard enalapril tablet
formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water;
2. To assess the relative bioavailability of 10 mg enalapril administered as
orodispersible minitablets (ODMT) dispersed in the oral cavity versus a standard
enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with
water.
Secondary objectives:
1. To assess whether the PK of enalapril is affected when the orodispersible minitablet
(ODMT) is entirely swallowed with water versus dispersion in the oral cavity.
2. To assess the general safety and tolerability including local tolerability and
palatability of enalapril administered as orodispersible minitablet (ODMT).
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy male and female subjects aged between 18 and 55 years, inclusive.
2. Body mass index (BMI) between 18. 5 and 30 kg/m2 inclusive (BMI = weight/height2).
3. Non-smoker (not smoked for at least 3 months prior to screening).
4. Physical examinations, clinical laboratory values, vital signs and ECGs are
clinically acceptable to the investigator.
5. Subjects must have signed an informed consent document indicating that they
understand the purpose of, and procedures required for the study and are willing to
participate in the study and comply with the study procedures and restrictions.
Exclusion Criteria:
1. History or evidence of clinically significant disorder (including psychiatric),
condition or disease that, in the opinion of the investigator would pose a risk to
subject safety or interfere with the study evaluation, procedures, or completion.
2. Women who are lactating/breastfeeding.
3. Women planning to become pregnant during the duration of the study.
4. Men with pregnant partners or whose partners plan to become pregnant during the
study.
5. Positive pregnancy test (women) on screening or predose.
6. A baseline systolic BP ≥ 140 or < 90 mmHg and/or a baseline diastolic BP of ≥ 90 or
<50 mmHg. A baseline ECG QTcB > 440 ms (males) or >450 ms (females) or heart rate
>100 bpm.
7. Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface
antigen, or hepatitis C antibodies at screening.
8. Known substance abuse (eg, alcohol, illicit or illegal drugs) within 1 year of
dosing.
9. Positive test for drug or alcohol use at screening. If the retest during the
screening period is negative, subject can be included.
10. Inability or unwillingness to refrain from alcohol consumption 24 hours prior to
study visits and to limit consumption throughout the course of the study.
11. Has had major surgery, donated or lost 500 mL or more of blood within 2 months of the
first study treatment or has a history of chronic anemia.
12. Receiving or has received any investigational drug (or is currently using an
investigational drug or device) within 30 days or 5 half-lives (whichever is longer),
prior to receiving the first study treatment.
13. Use of any over-the-counter or prescription medications within 7 days or 5 half-lives
(whichever is longer), prior to receiving the first study treatment. However, if a
subject has to use medication within 7 days of the first study drug administration,
he/she can be included in the study the study if according to the investigator the
medication is not relevant within the context of the trial. Paracetamol (up to 2 g
per day) for analgesia, and hormonal birth control medication will be allowed.
14. Use of any herbal medicines (eg. St. John's wort), vitamins, and supplements consumed
by the subject within 7 days prior to receiving the first study treatment. However,
if a subject has used herbal medicines (eg, St. John's wort), vitamins, and
supplements medication within 7 days of the first study drug administration, he/she
can be included in the study if according to the investigator the medication is not
relevant within the context of the trial.
Locations and Contacts
Center for Clinical Pharmacology, UZ Leuven, Leuven 3000, Belgium
Additional Information
Starting date: August 2014
Last updated: September 26, 2014
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