Telmisartan, Amlodipine and Combination in Healthy Subjects
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.
Timeline
- Start
- 2010-08
- Primary completion
- 2010-11
- Completion
- —
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Telmisartan 80mg, Amlodipine 5mg vs Telmisartan 80mg; p = 0.0107; gMean Ratio 109.22 (90% CI 99.45 to 119.95) NCT01181011 ↗
registry analysis (non-inferiority or equivalence test); Telmisartan 80mg, Amlodipine 5mg vs Telmisartan 80mg; p = 0.0139; gMean Ratio 109.84 (90% CI 99.96 to 120.71) NCT01181011 ↗
registry analysis (non-inferiority or equivalence test); Telmisartan 80mg, Amlodipine 5mg vs Telmisartan 80mg; p = 0.0126; gMean Ratio 97.57 (90% CI 84.643 to 112.472) NCT01181011 ↗
registry analysis (non-inferiority or equivalence test); Telmisartan 80mg, Amlodipine 5mg vs Amlodipine 5mg; p = 0.0011; gMean Ratio 109.7 (90% CI 102.87 to 117.07) NCT01181011 ↗
registry analysis (non-inferiority or equivalence test); Telmisartan 80mg, Amlodipine 5mg vs Amlodipine 5mg; p = 0.0006; gMean Ratio 108.8 (95% CI 102.1 to 116.0) NCT01181011 ↗
registry analysis (non-inferiority or equivalence test); Telmisartan 80mg, Amlodipine 5mg vs Amlodipine 5mg; p = 0.000; gMean Ratio 106.7 (90% CI 100.9 to 112.9) NCT01181011 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 5 mg | — |
| Subject | Telmisartan | Other / unclassified | 80 mg | — |
Indications
No indication recorded.