Influence of Food on the Bioavailability of Telmisartan 40 mg/HCTZ 12.5 mg Fixed-dose Combination and of Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination in Japanese Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

NCT02276378 Phase 1 COMPLETED

To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2008-07

Conditions

• Healthy

Interventions

• Telmisartan low
• Telmisartan high
• Hydrochlorothiazide (HCTZ)
• Japanese meal

Primary outcomes

• Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) — Up to 72 hours after drug administration
• The maximum measured concentration of the analyte in the plasma (Cmax) — Up to 72 hours after drug administration