Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Healthy Clinical Trial

Official title:

Bioequivalence of Telmisartan Administrated in Two Different Ways: Both in Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg Tablet and Amlodipine 5mg Tablet in Concomitant Use in Healthy Male Volunteers. (an Open-label, Randomized, Single-dose, Four-period Replicated Crossover Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344629
• Other study ID #: 1235.28
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2011
• Last updated: February 28, 2014
• Start date: April 2011

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

Inclusion criteria:

1. Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests

2. Age: =20 and =35 years

3. Body weight: =50 kg and =80 kg

4. Body mass index (BMI): =18.0 and =25.0 kg/m2

Exclusion criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

2. Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders

3. Chronic or relevant acute infections

4. Any clinical relevant findings in laboratory test results deviating from normal

5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test

6. History of surgery of the gastrointestinal tract (except appendectomy)

7. History of relevant orthostatic hypotension, fainting spells, or blackouts

8. Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin receptor blocker, or to any other dihydropyridine calcium channel blocker compound

9. Intake of drugs with a long half-life (=24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration

10. Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration

11. Participation in another trial with an investigational drug within 1 months or less than 10 times of half-lives of the investigational products before drug administration

12. Smoker (=20 cigarettes/day)

13. Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake)

14. Drug abuse

15. Blood donation (more than 100 mL within 4 weeks before drug administration)

16. Excessive physical activities (ex. Marathon etc) within 1 week before drug administration

17. Intake of alcohol within 2 days before drug administration

18. Inability to comply with dietary regimen of the study site

19. Inability to refrain from smoking during trial days

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Telmisartan/Amlodipin FDC
Telmisartan80mg/Amlodipin5mg FDC
• Telmisartan
Telmisartan 80 mg tablet
• Amlodipin
Amlodipin 5mg tablet

Locations

Country	Name	City	State
Japan	1235.28.001 Boehringer Ingelheim Investigational Site	Kumamoto, Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-tz	Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No
Primary	Cmax	maximum measured concentration of Telmisartan in plasma	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No
Secondary	AUC0-8	area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No
Secondary	Tmax	time from dosing to the maximum concentration of Telmisartan in plasma	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No
Secondary	?z	terminal rate constant of Telmisartan in plasma	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No
Secondary	t1/2	terminal half-life of Telmisartan in plasma	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No
Secondary	MRTpo	mean residence time of Telmisartan in the body after oral administration	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	No

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