Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers

NCT ID: NCT02260050

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

Brief Summary

To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WAL 801 CL new formulation

Group Type: EXPERIMENTAL

WAL 801 CL dry syrup new formulation

Intervention Type: DRUG

WAL 801 CL conventional formulation

Group Type: ACTIVE_COMPARATOR

WAL 801 CL dry syrup conventional formulation

Intervention Type: DRUG

Interventions

WAL 801 CL dry syrup new formulation

Intervention Type: DRUG

WAL 801 CL dry syrup conventional formulation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males according to the following criteria:

• Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature (BT)), 12-lead ECG, clinical laboratory tests (including gastric acidity (GA) test)
• No finding of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 20 and Age ≤ 35 years
• BMI ≥ 18.5 and BMI ≤ 25 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to Screening Phase and prior to Treatment Phase (Day -1 in Treatment period 1) in accordance with Japanese Good Clinical Practice (GCP)

Exclusion Criteria

• Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• History of surgery of gastrointestinal tract with the exception of appendectomy
• History of (and/or current) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Current chronic or relevant acute infections
• History of hypersensitivity (including drug allergy) or current allergic disorders which are deemed relevant to the trial by the investigator or the sub-investigators; e.g. bronchial asthma, allergic rhinitis, atopic dermatitis and food allergy (excluding asymptomatic seasonal rhinitis/hay fever)
• 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 drug administration and during Treatment Phase
• Use of any drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation, within 10 days prior to administration and during Treatment Phase
• Participation in Phase I trial of new chemical entities within 4 months prior to drug administration and during the trial, or in another clinical trial within 3 months prior to drug administration and during Treatment Phase
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking during hospitalization
• Alcohol abuse (more than 60 g/day) (confirmed by interview)
• Drug abuse (confirmed by interview)
• Whole blood donation (400 mL within 3 months or more than 100 mL within 4 weeks prior to drug administration or during the trial) or component blood donation (within 2 weeks prior to drug administration or during Treatment Phase)
• Excessive physical activities (within 48 hours prior to each treatment period and during hospitalisation)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of study centre

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

262.284

Identifier Type: -

Identifier Source: org_study_id