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

NCT01344629 | Completed Phase 1 Results

• 1 other identifier: 1235.28
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• AUC0-∞

  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

• Tmax

  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

• λz

  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

• t1/2

  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

• MRTpo

  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

Study Arms (2)

Telmisartan80mg/Amlodipin5mg FDC

EXPERIMENTAL

single-dose, four-period replicated crossover design

Drug: Telmisartan/Amlodipin FDC

Telmisartan80mgtab + Amlodipin5mg tab

EXPERIMENTAL

single-dose, four-period replicated crossover design

Drug: Telmisartan; Drug: Amlodipin

Interventions

Telmisartan/Amlodipin FDC DRUG

Telmisartan80mg/Amlodipin5mg FDC

Telmisartan80mg/Amlodipin5mg FDC

Telmisartan DRUG

Telmisartan 80 mg tablet

Telmisartan80mgtab + Amlodipin5mg tab

Amlodipin DRUG

Amlodipin 5mg tablet

Telmisartan80mgtab + Amlodipin5mg tab

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age: =20 and =35 years
• Body weight: =50 kg and =80 kg
• Body mass index (BMI): =18.0 and =25.0 kg/m2

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
• Chronic or relevant acute infections
• Any clinical relevant findings in laboratory test results deviating from normal
• 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
• History of surgery of the gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• 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
• 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
• 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
• 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
• Smoker (=20 cigarettes/day)
• Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 mL\] of sake)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks before drug administration)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1235.28.001 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, Japan

Location

MeSH Terms

Interventions

Telmisartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Last Updated: March 28, 2014
• Results First Posted: August 27, 2012

Record last verified: 2014-02

Locations

JP (1)