Telmisartan, Amlodipine and Combination in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01181011
First received: August 10, 2010
Last updated: July 15, 2014
Last verified: July 2014
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • AUC_0-tz of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • AUC_0-∞ of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • Cmax of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Tmax of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • λz of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • MRT_po of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • t_½ of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • CL/F of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • V_z/F of Amlodipine [ Time Frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs ] [ Designated as safety issue: No ]
  • Number of Participants With at Least One Treatment Emergent Adverse Event [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01181011     History of Changes
Other Study ID Numbers: 1235.30
Study First Received: August 10, 2010
Results First Received: November 21, 2011
Last Updated: July 15, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014