None listed
Conditions
Interventions
Intervention1: Test product Misoprostol 200mcg tablets (Two tablets of Misoprostol 200 mcg): Test product Misoprostol 200mcg tablets (Two tablets of Misoprostol 200 mcg) Manufactured by Mylan Laborato
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: i. Subjects who are able to understand the objective of the study and provide written informed consent. ii. Subjects must be healthy, female, adult, human beings within 18-40years of age (both inclusive) weighing at least 50 kgs. iii. Having a Body Mass Index (BMI) between 18.50 and 24.90 (both inclusive), calculated as weight in Kg/(height in m)2. iv. Subjects must be of normal health as determined by medical history and physical examination performed within 28 days prior to the Check-in of first period. v. Have normal ECG, chest X-ray and vital signs (Systolic blood pressure-90 to 140 mm/Hg; Diastolic blood pressure-60 to 90 mm/Hg, Radial Pulse-60 to 100 per minute and oral temperature 95-99oF). vi. Subjects whose screening laboratory values are within normal limits or laboratory abnormalities considered by the investigator to be of no clinical significance. vii. Study participant should be normal results with PAP smear and mammogram viii. Study participant should be negative with serum pregnancy test at screening, check-in. ix. Subjects with child bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) x. Availability of the subject for the entire study and willingness to adhere to the protocol requirements as evidenced by written informed consent.
Exclusion criteria
Exclusion criteria: i. Subjects with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease. ii. History of hypersensitivity or idiosyncratic reaction to Misoprostol or any other related drugs. iii. Subjects with current acute vaginal infection. iv. Subjects with Pelvic or vaginal surgery in prior 60 days. v. Use of hormonal contraception in the past year vi. Use of any type of vaginal moisturizer, douche, vaginal prebiotic or probiotic, or soap in the vagina in the past month vii. Unwilling to abstain from use of any non-study vaginal moisturizer, vaginal estrogen, douche, or soap in the vagina throughout the trial. viii. Subjects who are pregnant (women with child bearing potential) or planning to become pregnant during the study. ix. Female volunteers who are currently breast feeding. x. Consumption of grapefruit and its juice for the past 03 days prior to the dosing. xi. Subjects who have taken over the counter (OTC) or prescribed medications within 07 days and enzyme modifying medication or any systemic medication (either prescribed or over-the-counter Including Herbal Preparation) during the last 07 days initiation and till completion of study. Use of MAOI (Mono Amino Oxidase Inhibitors) within 14 days prior to study admission. xii. Subjects who are in habit of consuming Ghutka and panmasala products. xiii. History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products. xiv. Subject had diarrhea in the last 24 hrs which leads to de-hydration xv. Study participants who have participated in any other clinical investigation using experimental drug or had blood loss of more than 350 mL at single occasion in the past 90 days. xvi. Study participants with positive breath alcohol, positive urine screen for drugs of abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the bioequivalence of Test product Misoprostol 200mcg tablets (Two tablets of Misoprostol 200 mcg) Manufactured by Mylan Laboratories Ltd., India with Reference Product Cytotec® (Two Tablets of Misoprostol 200mcg) of Pfizer in healthy, female adult human subjects under fasting conditionsTimepoint: 0.00 hrs, 0.083 hrs, 0.167 hrs, 0.25 hrs, 0.33 hrs, 0.50 hrs, 0.67 hrs, 0.83 hrs, 1.00 hrs, 1.25 hrs, 1.50 hrs, 1.75 hrs, 2.00 hrs, 3.00 hrs, 4.00 hrs and 6.00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To evaluate the safety and tolerability of the investigational products.Timepoint: 0.00 hrs, 0.083 hrs, 0.167 hrs, 0.25 hrs, 0.33 hrs, 0.50 hrs, 0.67 hrs, 0.83 hrs, 1.00 hrs, 1.25 hrs, 1.50 hrs, 1.75 hrs, 2.00 hrs, 3.00 hrs, 4.00 hrs and 6.00 hrs | — |
Countries
India
Contacts
Public ContactDr C Gayatri Devi
ActimusBiosciences
Outcome results
None listed