None listed
Conditions
Interventions
Intervention1: Withania somnifera extract (WSE) capsule: 400 mg (two 200 mg capsules in sequence) once a day
Control Intervention1: Nil: Nil
Sponsors
Phytoveda Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all the following criteria will be eligible for the study: 1.Healthy male and female subjects aged between 18 and 45 years (both inclusive). 2.Female subjects must have a negative urine pregnancy test prior to housing. 3.Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study. 4.Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study. 5.Subjects with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg. 6.Subjects in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests). 7.Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording. 8.Subjects having a normal or clinically not significant chest x-ray (P/A view). 9.A negative alcohol breath test result. 10.Subject able to communicate effectively and provide written informed consent. 11.Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee. 12.Subjects that can provide adequate evidence of their identity. 13.Availability of volunteers for the entire study duration. 14.Ability to fast for at least 14.00 hours and consume standard meals.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will not be eligible for the study: 1.Known hypersensitivity to Ashwagandha (Withania somnifera) or related drugs or any component of this medication. 2.Incapable of understanding the informed consent information. 3.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder. 4.Any treatment that could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study. 5.History or presence of alcoholism or drug abuse. 6.History or presence of asthma, urticaria, or other allergic reactions. 7.History or presence of gastric and/or duodenal ulceration. 8.History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion. 9.History or presence of cancer. 10.Difficulty with donating blood. 11.Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week prior to study initiation and throughout the study. 12.Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study. 13.Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study. 14.Subject consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study. 15.Subject consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours prior to initiation of the study and throughout the study. 16.Major illness during the 90 days before screening. 17.Participation in a drug research study within 90 days of screening. 18.Donation of blood within 90 days of screening. 19.Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL. 20.History or presence of easy bruising or bleeding. 21.Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study. 22.Male and female volunteers unwilling to employ appropriate contraceptive measures to ensure that their partner will not get pregnant during the study till 07 days after the completion of the study. 23.Male volunteers willing to donate sperm during the study till 07 days after the completion of the study. 24.Females of childbearing potential with any one of the following reported and documented on the medical history: i.Postmenopausal with spontaneous amenorrhea for at least one year, or ii.Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii.Total hysterectomy and an absence of bleeding for at least 3 months. iv.Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months before the study or used hormonal contraceptives within 07 days before dosing; 25.Pregnant women and nursing moth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study will be to assess: 1.Pharmacokinetics parameters like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel will be calculated from the concentration Vs. time data.Timepoint: PK blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 9.00, 12.00, and 24.00 hrs. (Total 13 Time points). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study will be to assess: 1.Screening, pre-dose, and post-dose vital signs. 2.Chest X-ray at screening. 3.Clinical examination, ECGs, and clinical laboratory testing (hematology, blood chemistry, and urinalysis) at screening and end of the study. 4.Adverse events, serious adverse events throughout the study. 5.Tolerability of the investigational product from administration to end of the study.Timepoint: From screening to end of the study | — |
Countries
India
Contacts
Public ContactMr Anirudh Mehta
Phytoveda Pvt Ltd
Outcome results
None listed