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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: WAL 801 CL dry syrup new formulation

Drug: WAL 801 CL dry syrup conventional formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02260050

262.284

Details and patient eligibility

About

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

Enrollment

34 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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