None listed
Conditions
Interventions
Intervention1: Nafithromycin (WCK 4873) Oral Tablet 400 mg: Nafithromycin (WCK 4873) Oral Tablet 400 mg
Wockhardt Limited, India
Control Intervention1: Nafithromycin (WCK 4873) Oral suspension 200 m
Sponsors
Wockhardt Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Has understood and signed the informed consent form to participate in the study. Healthy subjects between 18.0 and 45.0 years of age both inclusive and body weight not less than 50 Kgs. Having a Body mass index between 18.5 and 30.0 both inclusive, calculated as (weight in kg) / (height in meter) 2. Having no significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during screening. Normal 12 lead ECG and Blood Pressure. Normal X-ray chest Postero-anterior view. Having Negative Breath Alcohol Test. Having Negative Urine Screen for Drugs of abuse viz Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Morphine and Tetrahydrocannabinol Marijuana. No history of tobacco use. Defined as smoking or the use of snuff chewing tobacco and other nicotine or nicotine containing products during the 06 months before the study check in procedures For Male Subjects Subjects willing to follow approved birth control methods a double barrier method for the duration of the study as judged by the investigator, such as a double barrier method condom with spermicide, Condom with diaphragm, or abstinence, Subjects should also not donate sperm during study period from the first study dose and willing to continue until duration equal to 90 days post from last IP dose. For Female Subjects Subject having negative urine pregnancy test at screening and negative serum beta-hCG pregnancy test on check in of period I. Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as intrauterine device IUD, abstinence or double barrier contraception, i.e., condom and diaphragm, condom and spermicidal or foam., or Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above Surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.
Exclusion criteria
Exclusion criteria: Personal or family history of allergy or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator would compromise the safety of the subject or the study. Evidence of impairment of renal, hepatic, neurological, cardiac, lungs or gastrointestinal function. History of any psychiatric disorders example depression, mental illness or suicidal attempts, behavioural changes, delusions, hallucinations and psychosis The Bazett Corrected QTc Value of screening ECG is more than 430 ms, upto 430ms is acceptable. History of Myasthenia gravis Consumption of alcohol within 48 hours prior to IP administration or difficulty in abstaining alcohol for the duration of the study. Participation in any clinical trial within past 90 days. Donation of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of investigation products. Receipt of any prescription drug therapy or over-the-counter drugs two weeks prior to receiving the first dose of investigational product which potentially modify kinetics or dynamics of investigational product or repeated use of drugs within the last two weeks. Difficulty in swallowing tablets or suspension. Inaccessibility of veins either in left and or right forearm. Evidence of skin lesion at the site of vein puncture except during recently done screening at CPB department. Use of any recreational drugs or history of drug addiction or which in the opinion of the Investigator, would compromise the safety of the subject or the study. Consumption of products like coffee, tea, cola drinks, chocolate containing xanthine, food or beverages prepared from grapefruit or grapefruit juice within 48 hours prior to receiving investigational products. Female subjects who are currently pregnant or lactating. Investigator or Physician opinion that it is not in benefit of subject or study to participate into the study Subjects with GFR Values of equal to less than 60
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of geometric least squares means for the lntransformed parameters of Nafithromycin are to be within 80.00 to 125.00 % Bioequivalence range and corresponding 90% confidence interval calculated from the exponential of the difference between the product A and product B for the ln-transformed parameters Cmax, AUC0-t and AUC0-â??of Nafithromycin are to be within the 80.00 to 125.00% Bioequivalence rangeTimepoint: 0.00, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 12.00, 15.00, 18.00 and 24.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary variables: Tmax, AUC_%Extrap, t1/2 and KelTimepoint: 0.00, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 12.00, 15.00, 18.00 and 24.00 hours | — |
Countries
India
Contacts
Public ContactDr Alok Pote MBBS
Wockhardt Limited
Outcome results
None listed