Telmisartan and Amlodipine Versus Monocomponent Tablets

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.