Phase 1
Completed N=28
Telmisartan, Amlodipine and Combination in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01181011 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: 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) — 3200; 2940 ng·h/mL — p=0.0107
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
3200; 2940 | 0.0107 sig |
| PRIMARY Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan |
3420; 3140 | 0.0139 sig |
| PRIMARY The Maximum Observed Plasma Concentration (Cmax) of Telmisartan |
461; 480 | 0.0126 sig |
| PRIMARY AUC_0-tz of Amlodipine |
206; 192 | 0.0011 sig |
| PRIMARY AUC_0-∞ of Amlodipine |
225; 210 | 0.0006 sig |
| PRIMARY Cmax of Amlodipine |
4.72; 4.43 | 0.000 sig |
| SECONDARY Time to Attain Cmax (Tmax) of Telmisartan |
1.22; 1.16 | — |
| SECONDARY Terminal Rate Constant in Plasma (λz) of Telmisartan |
0.0305; 0.0323 | — |
| SECONDARY Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po) |
20.0; 18.4 | — |
| SECONDARY Elimination Half-life (t_½) of Telmisartan |
27.0; 25.0 | — |
| SECONDARY Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F) |
31.0; 37.3 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan |
1021; 1135 | — |
| SECONDARY Tmax of Amlodipine |
6.88; 7.20 | — |
| SECONDARY λz of Amlodipine |
0.0305; 0.0323 | — |
| SECONDARY MRT_po of Amlodipine |
44.3; 43.7 | — |
| SECONDARY t_½ of Amlodipine |
38.8; 38.6 | — |
| SECONDARY CL/F of Amlodipine |
22.7; 25.1 | — |
| SECONDARY V_z/F of Amlodipine |
1241; 1353 | — |
| SECONDARY Number of Participants With at Least One Treatment Emergent Adverse Event |
4; 2; 4 | — |
| SECONDARY Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities |
0; 0; 0; 0; 0; 0 | — |
Eligibility 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
- No adequate contraception during the study and until 1 month of study completion 27. Lactation period
Data sourced from ClinicalTrials.gov (NCT01181011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.