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Telmisartan, Amlodipine and Combination in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181011
First Posted: August 13, 2010
Last Update Posted: July 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose

To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.

To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects.

To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.


Condition Intervention Phase
Healthy Drug: amlodipine/telmisartan/combination Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 (AUC_0-tz) [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • The Maximum Observed Plasma Concentration (Cmax) of Telmisartan [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • AUC_0-tz of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • AUC_0-∞ of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Cmax of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs ]

Secondary Outcome Measures:
  • Time to Attain Cmax (Tmax) of Telmisartan [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Terminal Rate Constant in Plasma (λz) of Telmisartan [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
    reflect the speed of drug elimination in vivo

  • Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po) [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Elimination Half-life (t_½) of Telmisartan [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F) [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Tmax of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • λz of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • MRT_po of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • t_½ of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • CL/F of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • V_z/F of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ]
  • Number of Participants With at Least One Treatment Emergent Adverse Event [ Time Frame: 4 weeks ]
  • Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities [ Time Frame: 4 weeks ]

Enrollment: 28
Study Start Date: August 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amlodipine/telmisartan/combination
all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
Drug: amlodipine/telmisartan/combination
patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  1. Healthy males and females
  2. Aged between 18 and 45 years
  3. Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2

Exclusion criteria

  1. Any finding of the medical examination deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  10. Use of drugs which might reasonably influence the results of the trial
  11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  12. Smoker
  13. Inability to refrain from smoking during 24 hours prior to dosing and during the trial
  14. Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  17. Excessive physical activities (within one week prior to administration or during the trial)
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. Inability to comply with dietary regimen of trial site
  20. A history of additional risk factors for torsade de pointes
  21. Any history of relevant low blood pressure
  22. Supine blood pressure at screening of systolic <110 mm Hg and diastolic < 60 mm Hg
  23. History of urticaria
  24. History of angioneurotic edema 25 Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion

26. No adequate contraception during the study and until 1 month of study completion 27. Lactation period

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181011


Locations
China
1235.30.86001 Boehringer Ingelheim Investigational Site
Shanghai, China
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01181011     History of Changes
Other Study ID Numbers: 1235.30
First Submitted: August 10, 2010
First Posted: August 13, 2010
Results First Submitted: November 21, 2011
Results First Posted: May 10, 2012
Last Update Posted: July 24, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Telmisartan
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists