A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions
Overview
- Phase
- Phase 1
- Intervention
- Telmisartan/Amlodipine Combination Tablet
- Conditions
- Hypertension
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Telmisartan/Amlodipine Fixed Dose
Telmisartan/Amlodipine medium fixed dose combination tablet once daily.
Intervention: Telmisartan/Amlodipine Combination Tablet
Amlodipine Monocomponent
Amlodipine Monocomponent 10mg tablet once daily
Intervention: Amlodipine Monocomponent
Outcomes
Primary Outcomes
Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
Time Frame: Day 1, Day 22
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
Maximum Observed Plasma Concentration (Cmax) of Amlodipine
Time Frame: Day 1, Day 22
Secondary Outcomes
- Time of Maximum Concentration of Amlodipine (TMAX)(Day 1, Day 22)