None listed
Conditions
Interventions
Intervention1: Dexamethasone 20 mg Tablets: Strength: 20 mg
Dose: 20 mg
Control Intervention1: Fortecortin® 4 mg tablets: Strength: 4 mg
Dose: 20 mg (5 × 4 mg tablets)
Sponsors
GALENpharma GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy, adult human subjects 18-45 years of age (both inclusive), and weight =50 Kg (BMI 18.5 to 30.0 kg/m² (including both)). 2.Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluations, 12- lead ECG and chest X-Ray (postero-anterior view). 3.Non-smokers and non-alcoholic. 4.Values within normal ranges for laboratory parameters upon evaluation by the investigator or physician. 5.Subjects able to communicate effectively. 6.Subjects willing to give written informed consent and adhere to all the requirements of this protocol. 7.Subject willing to abstain from all kinds of caffeine/xanthine containing foods or grapefruit or grapefruit juice from 72.00 hours prior to admission until the last post dose blood sample collection in each period. 8.Female subjects: •Postmenopausal for at least 1 year or •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject) or •Female of childbearing potential practicing an acceptable method of birth control for the duration of the study and at least two weeks thereafter as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, and intrauterine device (IUD) or abstinence.
Exclusion criteria
Exclusion criteria: 1.Volunteers having history of contraindication or hypersensitivity (e.g., anaphylaxis) to dexamethasone or related group of drugs. 2.A history of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. 3.A history of seizures, diabetes, migraine, osteoporosis, myasthenia gravis, cardiovascular (including hypertension and heart failure), pulmonary, neurological or psychiatric disease/disorder (including risk of suicide, also in the anamnesis), dermatological, endocrine, eye disorders (e.g., narrow- and wide-angle glaucoma, corneal ulcer and corneal injury), immunological (including immunosuppressed volunteers), hepatic, renal, hematopoietic, gastrointestinal (including enteroanastomosis), malignant, ongoing infectious diseases, history of tubercolosis, lymphadenitis after BCG vaccination, HbsAg-positive chronic active hepatitis, systemic mycoses and parasitosis or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician. 4.History of gastrointestinal (GI) inflammation (including ulcerative colitis and diverticulitis), bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine. 5.History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). 6.Eight weeks before until two weeks after vaccination with live vaccines. 7.Any known enzyme inducing or inhibiting drug taken within 30 days before the study. 8.Participation in a drug research study within 90 days prior to dosing of this study. 9.Blood loss or whole blood donation within 90 days prior to drug administration. 10.Consumption of high caffeine (more than 5 cups of coffee or tea/day). 11.History of addiction to any recreational drug or drug dependence. 12.An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons. 13.History of dehydration from diarrhea, vomiting or any other reason within a period of 72.00 hours prior to study admission of each period. 14.Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study admission of each period. 15.Positive results for alcohol consumption tests during the study admission of each period. 16.History of pre-existing bleeding disorder. 17.Difficulty with donating blood. 18.Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. 19.Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 20.Pulse rate less than 60 beats/minute or more than 100 beats/minute. 21.Use of any prescribed medication or OTC medicinal products including vitamins and herbal medicinal products during last two weeks preceding the first dosing. 22.Female volunteer who is pregnant, currently breast-feeding. 23.Female volunteers demonstrating a positive pregnancy test. 24.Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing. 25.Symptoms of COVID-19 or positive COVID-19 test result within the past 30 days. 26.History of rare hereditary problems of galactose intolerance, fructose intolera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Dexamethasone 20 mg Tablets of GALENpharma GmbH, Germany, with Fortecortin® 4 mg tablets (5 × 4 mg tablets) of Merck Healthcare Germany GmbH, Waldstraße 3, 64331 Weiterstadt, in normal, healthy, adult, human subjects under fed conditionsTimepoint: In each period, a total of 20 blood samples (05 mL of each) per subject will be collected at pre-dose (00.00 hour) and at 00.17, 00.33, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 10.00, 12.00, 16.00, and 24.00 hours post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of single oral dose of Dexamethasone 20 mg Tablets in normal, healthy, adult, human subjects under fed conditionsTimepoint: Clinical examination and vital signs (seated blood pressure, respiratory rate, radial pulse rate and body temperature) and well-being will be recorded at the time of admission and before discharge in each study period Vital signs (seated blood pressure, radial pulse rate and body temperature) and well-being will be recorded at 00.00 (Pre dose), 02.00, 05.00 and 11.00 hours after dosing, within ±45 minutes of scheduled time in each study period. | — |
Countries
India
Contacts
Public ContactDr Mallu Maheswara Reddy MBBS
Jeevan Scientific Technology Limited
Outcome results
None listed