Telmisartan, Amlodipine and Combination in Healthy Subjects

NCT01181011 | Completed Phase 1 Results

• 1 other identifier: 1235.30
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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)

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• The Maximum Observed Plasma Concentration (Cmax) of Telmisartan

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• AUC_0-tz of Amlodipine

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• AUC_0-∞ of Amlodipine

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• Cmax of Amlodipine

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs

Secondary Outcomes (14)

• Time to Attain Cmax (Tmax) of Telmisartan

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• Terminal Rate Constant in Plasma (λz) of Telmisartan

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• Elimination Half-life (t_½) of Telmisartan

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

• Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)

  3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Study Arms (1)

amlodipine/telmisartan/combination

EXPERIMENTAL

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

Interventions

amlodipine/telmisartan/combination DRUG

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.

amlodipine/telmisartan/combination

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1235.30.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

MeSH Terms

Interventions

telmisartan amlodipine combination

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

800-542-6257

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 13, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Last Updated: July 24, 2014
• Results First Posted: May 10, 2012

Record last verified: 2014-07

Locations

CN (1)