Telmisartan and Amlodipine Versus Monocomponent Tablets

NCT01278797 | Completed Phase 1 Results

• 1 other identifier: 1235.41
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)

  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

  Day 1, Day 22

Secondary Outcomes (1)

• Time of Maximum Concentration of Amlodipine (TMAX)

  Day 1, Day 22

Study Arms (2)

Telmisartan/Amlodipine Fixed Dose

ACTIVE COMPARATOR

Telmisartan/Amlodipine medium fixed dose combination tablet once daily.

Drug: Telmisartan/Amlodipine Combination Tablet

Amlodipine Monocomponent

ACTIVE COMPARATOR

Amlodipine Monocomponent 10mg tablet once daily

Drug: Amlodipine Monocomponent

Interventions

Telmisartan/Amlodipine Combination Tablet DRUG

Combination Tablet

Telmisartan/Amlodipine Fixed Dose

Amlodipine Monocomponent DRUG

Active Comparator

Amlodipine Monocomponent

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1235.41.0001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Last Updated: March 28, 2014
• Results First Posted: March 16, 2012

Record last verified: 2014-02

Locations

CA (1)