Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State

• Status: Completed
• Trial end date: 2018-12-19
• Target enrollment: 0
• Participant gender: All

Summary

This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmtechnology LLC
• Collaborator: Algorithme Pharma, An Altasciences Company
• Treatments: Telmisartan

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form (ICF)

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Healthy male or female adult volunteer

4. A female volunteer meeting one of the following criteria:

• (1) Physiological postmenopausal status, defined as the following:

• absence of menses for at least one year prior to the first study drug administration (not due to amenorrhea secondary to lactation); and

• Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening; OR

• (2) Surgical postmenopausal status, defined as the following:

• bilateral oophorectomy; and

• absence of menses for at least 90 days prior to the first study drug administration; and

• FSH levels ≥ 40 mIU/mL at screening; OR

• (3) Hysterectomy with FSH levels ≥ 40 mIU/mL at screening

If the postmenopausal volunteer has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and all the other inclusion criteria, the volunteer may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, inclusion of the volunteer will be based on medical judgment.

5. Volunteer aged at least 18 years but not older than 55 years

6. Volunteer with a body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively

7. Light-, non- or ex-smoker. A light smoker is defined as someone using 10.0 nicotine units or less per day for at least 90 days prior to the first study drug administration. An ex smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration

8. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator

9. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

1. Females who are pregnant according to the pregnancy test at screening

2. Seated blood pressure below 105/60 mmHg at the screening visit or prior to the first study drug administration

3. History of significant hypersensitivity to telmisartan or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs

4. Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects

5. History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy

6. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

7. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment

8. History of rare hereditary problems of fructose, galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption

9. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)

10. Any clinically significant illness in the 28 days prior to the first study drug administration

11. Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the volunteer as healthy

12. Any history of tuberculosis

13. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration

14. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests

15. Volunteers who have already been included in a previous group for this clinical study

16. Volunteers who took telmisartan in the 28 days prior to the first study drug administration

17. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration

18. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration

19. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration