- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278797
Telmisartan and Amlodipine Versus Monocomponent Tablets
February 28, 2014 updated by: Boehringer Ingelheim
A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions
This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- 1235.41.0001 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Healthy, non-smoking, male and/or post-menopausal/surgically sterile female subjects from 18 to 55 years of age.
Females who participate in this study must either:
- be post-menopausal for at least 1 year (no menstrual cycle for 12 consecutive months) and deemed post-menopausal by a physician based on screening clinical laboratory tests (Follicle stimulating hormone (FSH) and Luteinising Hormone (LH)
- provide proof of surgical sterility.
- Body Mass Index (BMI) greater than or equal to 19.0 and less than or equal to 30.0 kg/m2.
- No clinically significant findings in vital signs measurements and systolic blood pressure greater than or equal to 110 mmHg at screening.
- No clinically significant abnormal laboratory values.
- No clinically significant findings in a 12-lead electrocardiogram (ECG) and the time between the P and the R waves on the ECG (PR interval) less than or equal to 200 ms at screening.
- Have no significant diseases.
- Be informed of the nature of the study and give written consent prior to receiving any study procedure.
- Have no clinically significant findings from a physical examination.
Exclusion criteria:
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- History or presence of cardiovascular dysfunction (e.g. increased angina, myocardial infarction, outflow obstruction, congestive heart failure).
- History of clinically significant hypotension.
- Presence of hepatic dysfunction.
- Known history or presence of galactose or fructose intolerance, sucrase-isomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
- History of gastrointestinal tract surgery (appendectomy is permitted).
- Presence of clinically significant gastrointestinal disease or history of malabsorption within the last year.
- Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
- History of drug or alcohol addiction requiring treatment.
- Positive test result for serum hCG consistent with pregnancy (females only), HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone, and benzodiazepines) or urine cotinine.
- Difficulty fasting or consuming standard meals.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- Does not tolerate venipuncture.
- Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- On a special diet within 30 days prior to drug administration (e.g. liquid, protein, raw food diet).
- Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
Donation or loss of whole blood:
- Great than or equal to 50 mL and less than or equal to 499 mL within 30 days prior to dosing
- greater than or equal to 500 mL within 56 days prior to dosing.
- Females who have used hormonal contraceptives within 6 months prior to drug administration.
- Have had a tattoo or body piercing within 30 days prior to dosing.
- Known history or presence of hypersensitivity or idiosyncratic reaction to telmisartan, amlodipine, or any other drug substances with similar activity.
Use of any drugs known to:
- induce (e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole)
- inhibit (e.g. antidepressants (Selective Seratonin Reuptake Inhibitor (SSRI)I), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) hepatic drug metabolism within 30 days prior to drug administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Telmisartan/Amlodipine Fixed Dose
Telmisartan/Amlodipine medium fixed dose combination tablet once daily.
|
Combination Tablet
|
Active Comparator: Amlodipine Monocomponent
Amlodipine Monocomponent 10mg tablet once daily
|
Active Comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
Time Frame: Day 1, Day 22
|
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
|
Day 1, Day 22
|
Maximum Observed Plasma Concentration (Cmax) of Amlodipine
Time Frame: Day 1, Day 22
|
Day 1, Day 22
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of Maximum Concentration of Amlodipine (TMAX)
Time Frame: Day 1, Day 22
|
Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period
|
Day 1, Day 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
January 17, 2011
First Submitted That Met QC Criteria
January 17, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
March 28, 2014
Last Update Submitted That Met QC Criteria
February 28, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Telmisartan
- Telmisartan amlodipine combination
Other Study ID Numbers
- 1235.41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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