Telmisartan, Amlodipine and Combination in Healthy Subjects
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01181011
First received: August 10, 2010
Last updated: May 18, 2012
Last verified: May 2012
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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 Pharmaceuticals:
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
- 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
26. No adequate contraception during the study and until 1 month of study completion 27. Lactation period
Contacts and Locations
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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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: | May 18, 2012 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Amlodipine Telmisartan Benzoates Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013