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Completed

NCT Number: NCT01181011

Telmisartan, Amlodipine and Combination in Healthy Subjects

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.

Completed

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1235.30.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any finding of the medical examination deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts.
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • 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
  • Use of drugs which might reasonably influence the results of the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker
  • Inability to refrain from smoking during 24 hours prior to dosing and during the trial
  • Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A history of additional risk factors for torsade de pointes
  • Any history of relevant low blood pressure
  • Supine blood pressure at screening of systolic <110 mm Hg and diastolic < 60 mm Hg
  • History of urticaria
  • History of angioneurotic edema 25 Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
  • No adequate contraception during the study and until 1 month of study completion 27. Lactation period

Treatment and study plan

amlodipine/telmisartan/combination

Drug

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. AUC_0-tz of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  5. AUC_0-∞ of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  6. Cmax of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Tmax of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  8. λz of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  9. MRT_po of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  10. t_½ of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  11. CL/F of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  12. V_z/F of Amlodipine

    Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

  13. Number of Participants With at Least One Treatment Emergent Adverse Event

    Time frame: 4 weeks

  14. Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
First posted
Aug 13, 2010
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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